This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03993119
Collaborator
(none)
500
45
12.7
11.1
0.9

Study Details

Study Description

Brief Summary

This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.

Condition or Disease Intervention/Treatment Phase
  • Drug: Non-vitamin K antagonist oral anticoagulant

Study Design

Study Type:
Observational
Actual Enrollment :
500 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Non-Interventional, Cross-sectional Study to Describe NOACs Management in Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.
Actual Study Start Date :
Jul 30, 2019
Actual Primary Completion Date :
Aug 20, 2020
Actual Study Completion Date :
Aug 20, 2020

Arms and Interventions

Arm Intervention/Treatment
patients with NVAF

Drug: Non-vitamin K antagonist oral anticoagulant
Non-vitamin K antagonist oral anticoagulant

Outcome Measures

Primary Outcome Measures

  1. Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex [At the single study visit (Day 1).]

    Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported.

  2. Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex [At the single study visit (Day 1).]

    Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported.

  3. Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical) [At the single study visit (Day 1).]

    Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported.

  4. Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical) [At the single study visit (Day 1).]

    Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported.

  5. Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure [At the single study visit (Day 1).]

    Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported.

  6. Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure [At the single study visit (Day 1).]

    Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported.

  7. Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease [At the single study visit (Day 1).]

    Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported.

  8. Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease [At the single study visit (Day 1).]

    Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported.

  9. Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes [At the single study visit (Day 1).]

    Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported.

  10. Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes [At the single study visit (Day 1).]

    Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported.

  11. Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease [At the single study visit (Day 1).]

    Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported.

  12. Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease [At the single study visit (Day 1).]

    Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported.

Secondary Outcome Measures

  1. Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported.

  2. Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] Reported are Crcl values which are calculated according to: Cockcroft-Gault formula and CrCl values directly collected in the eCRF Cockcroft-Gault formula only Directly collected in the eCRF

  3. Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] The number of participants for each of the following creatinine clearance (CrCl) ranges is reported: CrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR) CrCl 60-89: Kidney damage with mild decreased GFR CrCl 30-59: Moderate decrease in GFR CrCl 15-29: Severe decrease in GFR CrCl <15: Kidney failure

  4. Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.

  5. Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported.

  6. Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.

  7. Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported.

  8. Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported.

  9. Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type [At the single study visit (Day 1).]

    Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels. For each reported laboratory parameter the values were categorized in two categories: Serum creatinine: Normal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females High/low value ALT: Normal values: 7-55 units per liter (UI/L) High/low values AST: Normal values: 8-48 UI/L High/low values Bilirubin: Normal values: 0.2-1.2 milligram per deciliter (mg/dl) High/low values Haemoglobin: Normal values: 12-18 gram/deciliter (g/dL) High/low values Platelets: Normal values: 150-450 x10^3/µL High/low values

  10. Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (day 1).]

    The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit. The date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for: All patients; Patients treated previously with vitamin K antagonists (VKA); Patients treated with NOAC as first anticoagulant .

  11. Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (day 1).]

    NVAF was categorized in four categories: Persistent; Long standing persistent; Permanent; Paroxysmal.

  12. Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type [At the single study visit (day 1).]

    The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. The EHRA categories are the following: 1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued.

  13. Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported.

  14. Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Coronary interventions were categorized in: Percutaneous coronary intervention and Coronary artery bypass grafting.

  15. Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Number of patients in each category of heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories: No; Yes.

  16. Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories: A - No objective evidence of cardiovascular disease B - Objective evidence of minimal cardiovascular disease C - Objective evidence of moderately severe cardiovascular disease D - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported.

  17. Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records.

  18. Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.

  19. Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported. The comorbidities which were included in the Charlson Comorbidity Index were the following: Myocardial infarction Congestive heart failure Peripheral vascular disease Cerebrovascular disease Dementia Chronic Obstructive Pulmonary Disease (COPD) Connective tissue disease Peptic ulcer disease Liver disease (No/Mild/Moderate to severe) Diabetes mellitus (No/Uncomplicated/End-organ damage) Hemiplegia Moderate to severe renal disease Solid Tumor (No/Localized/Metastatic) Leukaemia Lymphoma Acquired Immune Deficiency Syndrome (AIDS).

  20. Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Reported is the number of patients in each category of: Any history of thromboembolic events Transient Ischemic Attack (TIA) Ischemic stroke Haemorrhagic stroke Embolism systemic Deep vein thrombosis Pulmonary embolism. Any history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories: No Yes.

  21. Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type [At the single study visit (Day 1).]

    Number of patients in each category of stable angina, unstable angina, myocardial infarction with ST segment elevation and myocardial infarction without ST segment elevation according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Stable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories: Yes; No.

  22. Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type [At the single study visit (Day 1).]

    Total number of thromboembolic events, number of each type of thromboembolic events, number of stable and unstable anginas, and number of ST and non-ST myocardial infarction according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.

  23. Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival. Intracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories: No Yes.

  24. Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Total number of bleeding events and number of bleeding events for the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival.

  25. CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.

  26. Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke: Low risk (score 0 in male; score 1 in female) Moderate risk (score 1 in male; score 2 in female) High risk (score ≥2 in male; score ≥3 in female)

  27. HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding.

  28. Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk: Low risk (score 0) Intermediate risk (score 1-2) High risk (score ≥3)

  29. Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type [At the single study visit (Day 1).]

    Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported. The concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following: Angiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor Beta-blocker Calcium channel blockers Diuretics Amiodarone Statin Proton pump inhibitor H2-receptor antagonist Digoxin NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) Dronedarone Ketoconazole Cyclosporine Itraconazole Other antiarrhythmics

  30. Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]

    Number of patients in each category of previous Vitamin K Antagonists (VKA) treatment according to duration since the first non-vitamin K antagonist oral anticoagulant (NOAC) initiation is reported. Previous VKA treatment was categorized in 2 categories: No; Yes.

  31. Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported.

  32. Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]

    Duration of treatment (in years) is reported for: All patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA) Patients treated only with the VKA warfarin (row: Warfarin patients) Patients treated only with the VKA acenocoumarol (row: Acenocoumarol patients)

  33. Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for: All patients Patients treated previously with VKA Patients treated only with NOAC as anticoagulant (AC)

  34. First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported.

  35. Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients who changed (increased and decreased) and did not change the first non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.

  36. First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Treatment duration (in years) is reported for: Patients who stopped first NOAC treatment; Patients who did not stop the first NOAC treatment.

  37. Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Reason for first NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event

  38. Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Reason for first NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event

  39. Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported.

  40. Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported. Number of switches to a new NOAC was categorized in 3 categories: 0 switches 1 switch 2 switches.

  41. Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]

    Total number of switches according to duration since the first NOAC initiation is reported.

  42. Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]

    Reason for switch was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event

  43. Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported.

  44. Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients who changed (increased or decreased) and did not change the second non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.

  45. Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported.

  46. Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event

  47. Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Reason for second NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event

  48. Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported.

  49. Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients who changed (increased and decreased) and did not change the third non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.

  50. Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Duration of third NOAC treatment for patients who stopped NOAC treatment.

  51. Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Reason for Third NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event

  52. Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Reason for Third NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event

  53. Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Duration (in years) in NOAC treatment is reported for: All patients (patients who received or did not receive VKA) Patients treated previously with Vitamin K Antagonists (VKA) Patients treated with NOAC as first anticoagulant

  54. Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients in each category of total time in non-vitamin K antagonist oral anticoagulant (NOAC) treatment according to duration since the first NOAC initiation is reported. Total time in NOAC treatment was categorized in 4 categories: <1 year; 1-2 years; 2-3 years; >3 years.

  55. Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]

    Number of patients for each type of following antiplatelet treatment that the patients ever received is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned).

  56. Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation [At the single study visit (Day 1).]

    Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned).

  57. Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation [At the single study visit (Day 1).]

    Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported.

  58. Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score >4 was considered frail.

  59. Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type [At the single study visit (Day 1).]

    Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. CFS was categorized in two categories, according to this ranges: Frailty patients - CFS scoring >4 Non-frailty patients - CFS scoring ≤4

  60. Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type [At the single study visit (Day 1).]

    Reason for First NOAC usage was categorized in the following two categories: Primary prevention; Secondary prevention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients are willing and provide written informed consent prior to participate in this study

  • Patients ≥ 75 years-old at the time of the study visit.

  • Patients with a diagnosis of non-valvular atrial fibrillation (NVAF).

  • Patients who are being treated with NOAC treatment according to the indication approved in the Summary of Product Characteristics (SmPC).

  • Patients who have started the NOAC treatment at least 3 months prior to the study visit.

Exclusion Criteria:

Patients will be excluded from participating in this study if the following criterion is met:

  • Current participation in any clinical trial of a drug or device.

  • Patients who have any contraindication for NOAC treatment, according to the SmPC.

Contacts and Locations

Locations

Site City State Country Postal Code
1 H. Fundación Alcorcón Alcorcón, Madrid Spain 28922
2 Consulta Privada Almería Spain 4630
3 H. Dr. José Molina Orosa Arrecife, Las Palmas Spain 35500
4 Centro Médico San Juan de Dios Barakaldo, Bizkaia Spain 48901
5 H. Sagrat Cor Barcelona Spain 8029
6 H. Vall d'Hebron Barcelona Spain 8035
7 H. Sant Pau Barcelona Spain 8041
8 H. Vithas Internacional Xanit Benalmádena, Málaga Spain 29631
9 Ambulatorio Txurdinaga Bilbao Spain 48004
10 H. San Juan de Dios de Bormujos Bormujos, Sevilla Spain 41930
11 H. Provincial de Castellón Castellón Spain 12002
12 H. San Pedro Alcántara Cáceres Spain 10003
13 Consulta privada Dr. Ruiz Córdoba Spain 14006
14 H. Arquitecto Marcide Ferrol, A Coruña Spain 15405
15 H. de Jaen Jaen Spain 23007
16 H. U. de León León Spain 24008
17 H. Arnau de Vilanova Lleida Spain 25198
18 H. Lucus Augusti Lugo Spain 27003
19 H. La Princesa Madrid Spain 28006
20 Sanitas La Zarzuela Madrid Spain 28023
21 H. Central de la Defensa Gómez Madrid Spain 28047
22 H. Puerta de Hierro Majadahonda, Madrid Spain 28222
23 H. de Mataró Mataró, Barcelona Spain 8304
24 H. de Mendaro Mendaro, Guipúzcoa Spain 20850
25 H. Morales Meseguer Murcia Spain 30008
26 H. Virgen de la Arrixaca Murcia Spain 30120
27 Consulta Privada Málaga Spain 29002
28 Consulta privada Merelles Otero Ourense Spain 32003
29 Consulta Privada Ourense Spain 32003
30 H. Río Carrión Palencia Spain 34005
31 H. Son Llatzer Palma de Mallorca Spain 7198
32 H. de Navarra Pamplona Spain 31008
33 H. Comarcal de la Vega Baja San Bartolomé, Alicante Spain 3314
34 H. Moises Broggi Sant Joan Despí, Barcelona Spain 8970
35 H. Marqués de Valdecilla Santander Spain 39008
36 H. Álvarez-Buylla Santullano, Asturias Spain 33619
37 H. Virgen de la Macarena Sevilla Spain 41009
38 H. Virgen del Valle Toledo Spain 45071
39 H. de Torrejón Torrejón De Ardoz, Madrid Spain 28850
40 Consulta Privada Valencia Spain 46005
41 H. General de Valencia Valencia Spain 46014
42 Hospital La Fe Valencia Spain 46026
43 H. Virgen de la Concha Zamora Spain 49022
44 H. Clínico Lozano Blesa Zaragoza Spain 50009
45 H. Miguel Servet Zaragoza Spain 50009

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Mireia canals, (+34) 93 404 58 77, mireia.canals@boehringer-ingelheim.com

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03993119
Other Study ID Numbers:
  • 1160-0297
First Posted:
Jun 20, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details This was a non-Interventional, cross-sectional study to describe NOACs management in elderly patients with non-valvular atrial fibrillation (NVAF) in Spain. RE-BELD Study.
Pre-assignment Detail All subjects were screened for eligibility prior to participation in the study. Study visit was a routine visit, one of those visits already scheduled in order to follow up the patients' NVAF (Non-Valvular Atrial Fibrillation). Patients were considered included when they agreed to participate in the study and signed the informed consent form.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Period Title: Overall Study
STARTED 192 76 166 66
COMPLETED 192 76 166 66
NOT COMPLETED 0 0 0 0

Baseline Characteristics

Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban Total
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Total of all reporting groups
Overall Participants 192 76 166 66 500
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
80.83
(4.50)
80.89
(4.64)
82.29
(4.90)
82.02
(4.80)
81.48
(4.73)
Sex: Female, Male (Count of Participants)
Female
77
40.1%
46
60.5%
94
56.6%
33
50%
250
50%
Male
115
59.9%
30
39.5%
72
43.4%
33
50%
250
50%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Weight (Kg) (Kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilogram (kg)]
76.33
(11.53)
73.23
(13.57)
74.63
(13.40)
71.59
(12.41)
74.52
(12.75)
Weight categorical (Count of Participants)
≤60 kg
13
6.8%
12
15.8%
23
13.9%
14
21.2%
62
12.4%
>60 kg
130
67.7%
58
76.3%
132
79.5%
49
74.2%
369
73.8%
Height (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]
163.86
(8.28)
160.88
(8.88)
162.64
(9.61)
162.93
(7.75)
162.77
(8.86)
Body Mass Index (kilogram/meter^2 (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram/meter^2 (kg/m^2)]
28.58
(4.06)
28.13
(4.77)
28.32
(4.71)
27.46
(3.88)
28.27
(4.42)
Body mass index categorical (BMI cat) (Count of Participants)
Underweight: BMI< 18.5 kg/m2
0
0%
0
0%
0
0%
0
0%
0
0%
Normal weight: 18.5 kg m2≤ BMI≤ 25 kg/m2
25
13%
16
21.1%
36
21.7%
12
18.2%
89
17.8%
Overweight: 25 kg/m2< BMI≤ 30 kg/m2
61
31.8%
31
40.8%
55
33.1%
21
31.8%
168
33.6%
Obese: 30 kg/m2<BMI≤ 35 kg/m2
33
17.2%
17
22.4%
33
19.9%
9
13.6%
92
18.4%
Severely Obese: BMI> 35 kg/m2
8
4.2%
3
3.9%
12
7.2%
2
3%
25
5%
Caregiver (Count of Participants)
No
93
48.4%
41
53.9%
78
47%
39
59.1%
251
50.2%
Yes
76
39.6%
30
39.5%
82
49.4%
24
36.4%
212
42.4%
Place where patient is living (Count of Participants)
Home alone
17
8.9%
19
25%
23
13.9%
10
15.2%
69
13.8%
At home with partner/other family member/a friend
147
76.6%
52
68.4%
119
71.7%
45
68.2%
363
72.6%
Other's home (e.g. family member's)
15
7.8%
1
1.3%
17
10.2%
9
13.6%
42
8.4%
Nursing home
8
4.2%
0
0%
5
3%
2
3%
15
3%
Smoking habit (Count of Participants)
Ex-smoker
66
34.4%
17
22.4%
43
25.9%
19
28.8%
145
29%
Smoker
6
3.1%
1
1.3%
4
2.4%
1
1.5%
12
2.4%
Non-smoker
111
57.8%
57
75%
116
69.9%
45
68.2%
329
65.8%
Alcohol consumption (Count of Participants)
Casual or non-consumer
149
77.6%
66
86.8%
134
80.7%
56
84.8%
405
81%
Habitual
19
9.9%
6
7.9%
13
7.8%
3
4.5%
41
8.2%
Abuse
0
0%
0
0%
1
0.6%
1
1.5%
2
0.4%
Dependence
0
0%
0
0%
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex
Description Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Sex: Male Sex: Female
Arm/Group Description This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 250 250
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
115
59.9%
77
101.3%
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
30
15.6%
46
60.5%
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
72
37.5%
94
123.7%
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
33
17.2%
33
43.4%
Dabigatran 110 mg BID
56
29.2%
41
53.9%
Dabigatran 150 mg BID
59
30.7%
36
47.4%
Rivaroxaban 15 mg QD
8
4.2%
23
30.3%
Rivaroxaban 20 mg QD
22
11.5%
23
30.3%
Apixaban 2.5 mg BID
31
16.1%
43
56.6%
Apixaban 5 mg BID
41
21.4%
51
67.1%
Edoxaban 30 mg QD
13
6.8%
18
23.7%
Edoxaban 60 mg QD
20
10.4%
15
19.7%
2. Primary Outcome
Title Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex
Description Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Sex: Male Sex: Female
Arm/Group Description This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 250 250
Mean (Standard Deviation) [Years]
2.43
(2.19)
2.22
(1.83)
3. Primary Outcome
Title Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)
Description Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Age: 75-79 Years Age: 80-84 Years Age: ≥85 Years
Arm/Group Description This arm included all patients aged between 75-79 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included all patients aged between 80-84 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 210 152 138
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
93
48.4%
59
77.6%
40
24.1%
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
34
17.7%
23
30.3%
19
11.4%
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
59
30.7%
48
63.2%
59
35.5%
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
24
12.5%
22
28.9%
20
12%
Dabigatran 110 mg BID
22
11.5%
39
51.3%
36
21.7%
Dabigatran 150 mg BID
71
37%
20
26.3%
4
2.4%
Rivaroxaban 15 mg QD
10
5.2%
9
11.8%
12
7.2%
Rivaroxaban 20 mg QD
24
12.5%
14
18.4%
7
4.2%
Apixaban 2.5 mg BID
16
8.3%
21
27.6%
37
22.3%
Apixaban 5 mg BID
43
22.4%
27
35.5%
22
13.3%
Edoxaban 30 mg QD
7
3.6%
11
14.5%
13
7.8%
Edoxaban 60 mg QD
17
8.9%
11
14.5%
7
4.2%
4. Primary Outcome
Title Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical)
Description Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Age: 75-79 Years Age: 80-84 Years Age: ≥85 Years
Arm/Group Description This arm included all patients aged between 75-79 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included all patients aged between 80-84 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included all patients ≥85 years old who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 210 152 138
Mean (Standard Deviation) [Years]
2.33
(2.07)
2.32
(1.93)
2.32
(2.05)
5. Primary Outcome
Title Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure
Description Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Heart Failure: No Heart Failure: Yes
Arm/Group Description This arm included patients who participated in the study and had no prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 316 184
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
129
67.2%
63
82.9%
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
54
28.1%
22
28.9%
Current NOAC: Apixaban (2.5 mg BID and 5 mg patients)
96
50%
70
92.1%
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
37
19.3%
29
38.2%
Dabigatran 110 mg BID
63
32.8%
34
44.7%
Dabigatran 150 mg BID
66
34.4%
29
38.2%
Rivaroxaban 15 mg QD
21
10.9%
10
13.2%
Rivaroxaban 20 mg QD
33
17.2%
12
15.8%
Apixaban 2.5 mg BID
31
16.1%
43
56.6%
Apixaban 5 mg BID
65
33.9%
27
35.5%
Edoxaban 30 mg QD
16
8.3%
15
19.7%
Edoxaban 60 mg QD
21
10.9%
14
18.4%
6. Primary Outcome
Title Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure
Description Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Heart Failure: No Heart Failure: Yes
Arm/Group Description This arm included patients who participated in the study and had no prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 316 184
Mean (Standard Deviation) [Years]
2.27
(2.02)
2.41
(2.02)
7. Primary Outcome
Title Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease
Description Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Coronary Artery Disease: No Coronary Artery Disease: Yes
Arm/Group Description This arm included patients who participated in the study and had no coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 414 82
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
156
81.3%
35
46.1%
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
63
32.8%
13
17.1%
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
142
74%
21
27.6%
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
53
27.6%
13
17.1%
Dabigatran 110 mg BID
78
40.6%
19
25%
Dabigatran 150 mg BID
78
40.6%
16
21.1%
Rivaroxaban 15 mg QD
23
12%
8
10.5%
Rivaroxaban 20 mg QD
40
20.8%
5
6.6%
Apixaban 2.5 mg BID
62
32.3%
10
13.2%
Apixaban 5 mg BID
80
41.7%
11
14.5%
Edoxaban 30 mg QD
23
12%
8
10.5%
Edoxaban 60 mg QD
30
15.6%
5
6.6%
8. Primary Outcome
Title Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease
Description Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Coronary Artery Disease: No Coronary Artery Disease: Yes
Arm/Group Description This arm included patients who participated in the study and had no coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 414 82
Mean (Standard Deviation) [Years]
2.38
(2.02)
2.04
(1.99)
9. Primary Outcome
Title Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes
Description Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Diabetes: No Diabetes: Yes
Arm/Group Description This arm included patients who participated in the study and had no diabetes were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had diabetes and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 346 154
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
135
70.3%
57
75%
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
51
26.6%
25
32.9%
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
113
58.9%
53
69.7%
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
47
24.5%
19
25%
Dabigatran 110 mg BID
68
35.4%
29
38.2%
Dabigatran 150 mg BID
67
34.9%
28
36.8%
Rivaroxaban 15 mg QD
22
11.5%
9
11.8%
Rivaroxaban 20 mg QD
29
15.1%
16
21.1%
Apixaban 2.5 mg BID
51
26.6%
23
30.3%
Apixaban 5 mg BID
62
32.3%
30
39.5%
Edoxaban 30 mg QD
21
10.9%
10
13.2%
Edoxaban 60 mg QD
26
13.5%
9
11.8%
10. Primary Outcome
Title Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes
Description Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Diabetes: No Diabetes: Yes
Arm/Group Description This arm included patients who participated in the study and had no diabetes were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had diabetes and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 346 154
Mean (Standard Deviation) [Years]
2.39
(2.00)
2.17
(2.07)
11. Primary Outcome
Title Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease
Description Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Chronic Kidney Disease: No Chronic Kidney Disease: Yes
Arm/Group Description This arm included patients who participated in the study and had no chronic kidney disease were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had chronic kidney disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 408 92
Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients)
166
86.5%
26
34.2%
Current NOAC: Rivaroxaban (15 mg QD and 20 mg QD patients)
64
33.3%
12
15.8%
Current NOAC: Apixaban (2.5 mg BID and 5 mg BID patients)
130
67.7%
36
47.4%
Current NOAC: Edoxaban (30 mg QD and 60 mg QD patients)
48
25%
18
23.7%
Dabigatran 110 mg BID
76
39.6%
21
27.6%
Dabigatran 150 mg BID
90
46.9%
5
6.6%
Rivaroxaban 15 mg QD
19
9.9%
12
15.8%
Rivaroxaban 20mg QD
45
23.4%
0
0%
Apixaban 2.5 mg BID
43
22.4%
31
40.8%
Apixaban 5 mg BID
87
45.3%
5
6.6%
Edoxaban 30 mg QD
17
8.9%
14
18.4%
Edoxaban 60 mg QD
31
16.1%
4
5.3%
12. Primary Outcome
Title Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease
Description Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Chronic Kidney Disease: No Chronic Kidney Disease: Yes
Arm/Group Description This arm included patients who participated in the study and had no chronic kidney disease were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). This arm included patients who participated in the study and had chronic kidney disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC).
Measure Participants 408 92
Mean (Standard Deviation) [Years]
2.34
(2.05)
2.25
(1.89)
13. Secondary Outcome
Title Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 159 63 122 47
Mean (Standard Deviation) [milligram/deciliter (mg/dl)]
1.00
(0.23)
1.05
(0.29)
1.15
(0.41)
1.14
(0.39)
14. Secondary Outcome
Title Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] Reported are Crcl values which are calculated according to: Cockcroft-Gault formula and CrCl values directly collected in the eCRF Cockcroft-Gault formula only Directly collected in the eCRF
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 141 71 156 46
CrCl calculated by Cockcroft-Gault formula and CrCl values directly collected in the eCRF
63.50
(18.49)
55.42
(17.59)
54.45
(18.65)
53.04
(18.40)
Calculated by Cockcroft-Gault formula only
62.72
(18.82)
54.59
(17.79)
53.77
(19.35)
52.83
(18.84)
Directly collected in the eCRF
66.27
(17.27)
59.98
(16.47)
56.30
(16.69)
53.59
(17.69)
15. Secondary Outcome
Title Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] The number of participants for each of the following creatinine clearance (CrCl) ranges is reported: CrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR) CrCl 60-89: Kidney damage with mild decreased GFR CrCl 30-59: Moderate decrease in GFR CrCl 15-29: Severe decrease in GFR CrCl <15: Kidney failure
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 141 71 156 63
<15 ml/min/1.73m^2
0
0%
0
0%
0
0%
0
0%
15-29 ml/min/1.73m^2
0
0%
3
3.9%
10
6%
7
10.6%
30-59 ml/min/1.73m^2
72
37.5%
41
53.9%
92
55.4%
37
56.1%
60-89 ml/min/1.73m^2
55
28.6%
25
32.9%
46
27.7%
18
27.3%
≥90 ml/min/1.73m^2
14
7.3%
2
2.6%
8
4.8%
1
1.5%
16. Secondary Outcome
Title Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 128 62 138 59
Mean (Standard Deviation) [international units per liter (IU/L)]
24.13
(11.34)
21.60
(7.43)
25.57
(16.01)
20.81
(8.58)
17. Secondary Outcome
Title Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 127 66 143 62
Mean (Standard Deviation) [units per liter (UI/L)]
22.38
(13.66)
18.28
(8.95)
21.52
(17.81)
20.15
(20.76)
18. Secondary Outcome
Title Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 103 53 119 45
Mean (Standard Deviation) [milligram/deciliter (mg/dl)]
0.83
(0.47)
0.79
(0.51)
0.74
(0.47)
0.75
(0.37)
19. Secondary Outcome
Title Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 181 75 165 64
Mean (Standard Deviation) [gram/deciliter (g/dl)]
13.23
(1.66)
13.37
(1.61)
12.99
(1.90)
13.17
(1.92)
20. Secondary Outcome
Title Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 174 73 160 64
Mean (Standard Deviation) [x 10^3/microliter (μL)]
203.37
(60.50)
222.07
(77.13)
215.59
(81.48)
189.45
(68.80)
21. Secondary Outcome
Title Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type
Description Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels. For each reported laboratory parameter the values were categorized in two categories: Serum creatinine: Normal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females High/low value ALT: Normal values: 7-55 units per liter (UI/L) High/low values AST: Normal values: 8-48 UI/L High/low values Bilirubin: Normal values: 0.2-1.2 milligram per deciliter (mg/dl) High/low values Haemoglobin: Normal values: 12-18 gram/deciliter (g/dL) High/low values Platelets: Normal values: 150-450 x10^3/µL High/low values
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Normal levels
132
68.8%
44
57.9%
72
43.4%
32
48.5%
High/low levels
27
14.1%
19
25%
50
30.1%
15
22.7%
Normal levels
122
63.5%
61
80.3%
127
76.5%
59
89.4%
High/low levels
6
3.1%
1
1.3%
11
6.6%
0
0%
Normal levels
121
63%
65
85.5%
133
80.1%
59
89.4%
High/low levels
6
3.1%
1
1.3%
10
6%
3
4.5%
Normal levels
91
47.4%
46
60.5%
109
65.7%
41
62.1%
High/low levels
12
6.3%
7
9.2%
10
6%
4
6.1%
Normal levels
143
74.5%
63
82.9%
121
72.9%
50
75.8%
High/low levels
38
19.8%
12
15.8%
44
26.5%
14
21.2%
Normal levels
140
72.9%
65
85.5%
128
77.1%
48
72.7%
High/low levels
34
17.7%
8
10.5%
32
19.3%
16
24.2%
22. Secondary Outcome
Title Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit. The date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for: All patients; Patients treated previously with vitamin K antagonists (VKA); Patients treated with NOAC as first anticoagulant .
Time Frame At the single study visit (day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 165 66
All patients
4.78
(4.26)
5.85
(4.70)
6.01
(6.54)
5.63
(4.99)
Patients treated previously with VKA
6.30
(4.59)
7.95
(4.87)
7.60
(5.43)
7.59
(4.94)
Patients treated with NOAC as first anticoagulant
2.79
(2.71)
3.52
(3.21)
3.95
(7.28)
1.72
(1.74)
23. Secondary Outcome
Title Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description NVAF was categorized in four categories: Persistent; Long standing persistent; Permanent; Paroxysmal.
Time Frame At the single study visit (day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 189 71 160 63
Persistent
32
16.7%
11
14.5%
31
18.7%
12
18.2%
Long standing persistent
21
10.9%
3
3.9%
10
6%
5
7.6%
Permanent
99
51.6%
26
34.2%
66
39.8%
36
54.5%
Paroxysmal
37
19.3%
31
40.8%
53
31.9%
10
15.2%
24. Secondary Outcome
Title Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type
Description The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. The EHRA categories are the following: 1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued.
Time Frame At the single study visit (day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 188 69 157 62
1-none
47
24.5%
25
32.9%
52
31.3%
17
25.8%
2a-mild
83
43.2%
30
39.5%
70
42.2%
31
47%
2b-moderate
45
23.4%
11
14.5%
28
16.9%
11
16.7%
3-severe
10
5.2%
3
3.9%
6
3.6%
3
4.5%
4-disabling
3
1.6%
0
0%
1
0.6%
0
0%
25. Secondary Outcome
Title Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
No
171
89.1%
70
92.1%
151
91%
57
86.4%
Yes
16
8.3%
6
7.9%
14
8.4%
9
13.6%
No
178
92.7%
75
98.7%
160
96.4%
64
97%
Yes
11
5.7%
1
1.3%
6
3.6%
2
3%
No
167
87%
65
85.5%
148
89.2%
60
90.9%
Yes
22
11.5%
11
14.5%
17
10.2%
5
7.6%
No
166
86.5%
67
88.2%
151
91%
58
87.9%
Yes
23
12%
9
11.8%
15
9%
8
12.1%
26. Secondary Outcome
Title Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Coronary interventions were categorized in: Percutaneous coronary intervention and Coronary artery bypass grafting.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who underwent coronary interventions.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 22 11 17 5
Percutaneous coronary intervention
19
9.9%
9
11.8%
14
8.4%
4
6.1%
Coronary artery bypass grafting
3
1.6%
2
2.6%
3
1.8%
1
1.5%
27. Secondary Outcome
Title Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Number of patients in each category of heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories: No; Yes.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
No
129
67.2%
54
71.1%
96
57.8%
37
56.1%
Yes
63
32.8%
22
28.9%
70
42.2%
29
43.9%
No
156
81.3%
63
82.9%
142
85.5%
53
80.3%
Yes
35
18.2%
13
17.1%
21
12.7%
13
19.7%
No
170
88.5%
70
92.1%
152
91.6%
57
86.4%
Yes
19
9.9%
6
7.9%
11
6.6%
9
13.6%
No
46
24%
13
17.1%
22
13.3%
7
10.6%
Yes
146
76%
63
82.9%
144
86.7%
59
89.4%
No
76
39.6%
28
36.8%
68
41%
17
25.8%
Yes
116
60.4%
48
63.2%
97
58.4%
49
74.2%
28. Secondary Outcome
Title Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories: A - No objective evidence of cardiovascular disease B - Objective evidence of minimal cardiovascular disease C - Objective evidence of moderately severe cardiovascular disease D - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS with heart failure. NYHA classification for heart failure patients is missing.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 61 20 61 22
A - No objective evidence of cardiovascular disease
2
1%
0
0%
3
1.8%
0
0%
B - Objective evidence of minimal cardiovascular disease
39
20.3%
12
15.8%
25
15.1%
8
12.1%
C - Objective evidence of moderately severe cardiovascular disease
18
9.4%
6
7.9%
29
17.5%
12
18.2%
D - Objective evidence of severe cardiovascular disease
2
1%
2
2.6%
4
2.4%
2
3%
29. Secondary Outcome
Title Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 181 58 130 57
Mean (Standard Deviation) [percent ejection fraction (%)]
59.47
(9.66)
59.43
(10.45)
58.85
(12.27)
57.91
(12.57)
30. Secondary Outcome
Title Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 75 165 66
Mean (Standard Deviation) [Score on a scale]
5.26
(1.74)
5.39
(1.63)
5.99
(2.04)
6.27
(2.41)
31. Secondary Outcome
Title Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported. The comorbidities which were included in the Charlson Comorbidity Index were the following: Myocardial infarction Congestive heart failure Peripheral vascular disease Cerebrovascular disease Dementia Chronic Obstructive Pulmonary Disease (COPD) Connective tissue disease Peptic ulcer disease Liver disease (No/Mild/Moderate to severe) Diabetes mellitus (No/Uncomplicated/End-organ damage) Hemiplegia Moderate to severe renal disease Solid Tumor (No/Localized/Metastatic) Leukaemia Lymphoma Acquired Immune Deficiency Syndrome (AIDS).
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Myocardial infarction; No
176
91.7%
65
85.5%
147
88.6%
55
83.3%
Myocardial infarction; Yes
16
8.3%
11
14.5%
18
10.8%
11
16.7%
Congestive heart failure: No
129
67.2%
55
72.4%
96
57.8%
38
57.6%
Congestive heart failure: Yes
63
32.8%
21
27.6%
70
42.2%
28
42.4%
Peripheral vascular disease: No
172
89.6%
70
92.1%
151
91%
59
89.4%
Peripheral vascular disease: Yes
20
10.4%
5
6.6%
15
9%
7
10.6%
Cerebrovascular disease: No
153
79.7%
63
82.9%
133
80.1%
57
86.4%
Cerebrovascular disease: Yes
39
20.3%
13
17.1%
33
19.9%
9
13.6%
Dementia: No
188
97.9%
72
94.7%
153
92.2%
60
90.9%
Dementia: Yes
4
2.1%
4
5.3%
13
7.8%
6
9.1%
COPD: No
161
83.9%
66
86.8%
141
84.9%
54
81.8%
COPD: Yes
31
16.1%
10
13.2%
24
14.5%
12
18.2%
Connective tissue disease: No
189
98.4%
76
100%
164
98.8%
66
100%
Connective tissue disease: Yes
3
1.6%
0
0%
2
1.2%
0
0%
Peptic ulcer disease: No
187
97.4%
74
97.4%
156
94%
65
98.5%
Peptic ulcer disease: Yes
5
2.6%
2
2.6%
10
6%
1
1.5%
Liver disease: No
190
99%
74
97.4%
161
97%
65
98.5%
Liver disease: Mild
2
1%
2
2.6%
5
3%
1
1.5%
Liver disease: Moderate to severe
0
0%
0
0%
0
0%
0
0%
Diabetes mellitus: No
135
70.3%
51
67.1%
113
68.1%
47
71.2%
Diabetes mellitus: Uncomplicated
48
25%
18
23.7%
36
21.7%
11
16.7%
Diabetes mellitus: End-organ damage
9
4.7%
7
9.2%
17
10.2%
8
12.1%
Hemiplegia: No
191
99.5%
76
100%
164
98.8%
62
93.9%
Hemiplegia: Yes
1
0.5%
0
0%
2
1.2%
4
6.1%
Moderate to severe renal disease: No
166
86.5%
64
84.2%
130
78.3%
48
72.7%
Moderate to severe renal disease: Yes
26
13.5%
12
15.8%
36
21.7%
18
27.3%
Solid tumor: No
178
92.7%
69
90.8%
148
89.2%
57
86.4%
Solid tumor: Localized
13
6.8%
7
9.2%
16
9.6%
7
10.6%
Solid tumor: Metastatic
1
0.5%
0
0%
2
1.2%
2
3%
Leukaemia: No
192
100%
76
100%
166
100%
66
100%
Leukaemia: Yes
0
0%
0
0%
0
0%
0
0%
Lymphoma: No
192
100%
74
97.4%
165
99.4%
65
98.5%
Lymphoma: Yes
0
0%
2
2.6%
1
0.6%
1
1.5%
AIDS: No
192
100%
76
100%
165
99.4%
66
100%
AIDS: Yes
0
0%
0
0%
1
0.6%
0
0%
32. Secondary Outcome
Title Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Reported is the number of patients in each category of: Any history of thromboembolic events Transient Ischemic Attack (TIA) Ischemic stroke Haemorrhagic stroke Embolism systemic Deep vein thrombosis Pulmonary embolism. Any history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories: No Yes.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
No
153
79.7%
53
69.7%
120
72.3%
48
72.7%
Yes
39
20.3%
23
30.3%
46
27.7%
18
27.3%
No
180
93.8%
66
86.8%
155
93.4%
64
97%
Yes
10
5.2%
9
11.8%
8
4.8%
2
3%
No
173
90.1%
65
85.5%
146
88%
60
90.9%
Yes
19
9.9%
7
9.2%
20
12%
5
7.6%
No
189
98.4%
73
96.1%
163
98.2%
65
98.5%
Yes
1
0.5%
0
0%
1
0.6%
0
0%
No
191
99.5%
73
96.1%
164
98.8%
63
95.5%
Yes
0
0%
0
0%
0
0%
2
3%
No
190
99%
71
93.4%
162
97.6%
65
98.5%
Yes
1
0.5%
2
2.6%
2
1.2%
0
0%
No
190
99%
73
96.1%
161
97%
64
97%
Yes
1
0.5%
1
1.3%
3
1.8%
1
1.5%
33. Secondary Outcome
Title Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type
Description Number of patients in each category of stable angina, unstable angina, myocardial infarction with ST segment elevation and myocardial infarction without ST segment elevation according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Stable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories: Yes; No.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
No
187
97.4%
73
96.1%
161
97%
64
97%
Yes
4
2.1%
0
0%
4
2.4%
1
1.5%
No
190
99%
72
94.7%
158
95.2%
64
97%
Yes
1
0.5%
1
1.3%
6
3.6%
1
1.5%
No
183
95.3%
65
85.5%
153
92.2%
62
93.9%
Yes
8
4.2%
8
10.5%
11
6.6%
3
4.5%
No
183
95.3%
69
90.8%
156
94%
57
86.4%
Yes
8
4.2%
4
5.3%
8
4.8%
8
12.1%
34. Secondary Outcome
Title Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type
Description Total number of thromboembolic events, number of each type of thromboembolic events, number of stable and unstable anginas, and number of ST and non-ST myocardial infarction according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Total number of thromboembolic events
0.29
(0.66)
0.54
(1.24)
0.49
(1.19)
0.36
(0.69)
Number of Transient Ischemic Attack (TIA)
0.05
(0.22)
0.19
(0.63)
0.06
(0.25)
0.03
(0.17)
Number of ischemic strokes
0.10
(0.30)
0.10
(0.30)
0.13
(0.35)
0.09
(0.34)
Number of haemorrhagic strokes
0.01
(0.07)
0.00
(0.00)
0.01
(0.08)
0.00
(0.00)
Number of embolism systemic
0.00
(0.00)
0.00
(0.00)
0.00
(0.00)
0.03
(0.17)
Number of deep vein thrombosis
0.01
(0.14)
0.05
(0.37)
0.01
(0.11)
0.00
(0.00)
Number of pulmonary embolisms
0.01
(0.07)
0.01
(0.12)
0.02
(0.13)
0.02
(0.12)
Number of stable anginas
0.02
(0.14)
0.00
(0.00)
0.02
(0.15)
0.02
(0.12)
Number of unstable anginas
0.01
(0.07)
0.01
(0.12)
0.12
(0.74)
0.02
(0.12)
Number of myocardial infarctions with ST segment elevation
0.04
(0.20)
0.12
(0.37)
0.07
(0.25)
0.05
(0.21)
Number of myocardial infarctions without ST segment elevation
0.05
(0.24)
0.07
(0.30)
0.06
(0.29)
0.12
(0.33)
35. Secondary Outcome
Title Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival. Intracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories: No Yes.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
No
177
92.2%
68
89.5%
120
72.3%
56
84.8%
Yes
14
7.3%
8
10.5%
46
27.7%
9
13.6%
No
188
97.9%
74
97.4%
158
95.2%
64
97%
Yes
3
1.6%
2
2.6%
7
4.2%
1
1.5%
No
183
95.3%
73
96.1%
140
84.3%
62
93.9%
Yes
8
4.2%
3
3.9%
26
15.7%
3
4.5%
No
189
98.4%
76
100%
158
95.2%
63
95.5%
Yes
2
1%
0
0%
6
3.6%
2
3%
No
191
99.5%
75
98.7%
163
98.2%
64
97%
Yes
0
0%
1
1.3%
2
1.2%
1
1.5%
No
191
99.5%
76
100%
157
94.6%
62
93.9%
Yes
0
0%
0
0%
8
4.8%
3
4.5%
No
191
99.5%
76
100%
162
97.6%
64
97%
Yes
0
0%
0
0%
3
1.8%
1
1.5%
No
189
98.4%
76
100%
162
97.6%
65
98.5%
Yes
2
1%
0
0%
3
1.8%
0
0%
No
191
99.5%
73
96.1%
164
98.8%
64
97%
Yes
0
0%
3
3.9%
1
0.6%
1
1.5%
36. Secondary Outcome
Title Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Total number of bleeding events and number of bleeding events for the following bleeding types is reported: Intracranial Digestive Genitourinary Gingival Nasal Pulmonary Articular-muscular Conjunctival.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Number of total bleeding events
0.10
(0.42)
0.12
(0.36)
0.48
(1.01)
0.28
(0.82)
Number of intracranial events
0.02
(0.12)
0.03
(0.16)
0.04
(0.20)
0.02
(0.12)
Number of digestive events
0.06
(0.36)
0.04
(0.20)
0.27
(0.80)
0.06
(0.30)
Number of genitourinary events
0.01
(0.10)
0.00
(0.00)
0.04
(0.19)
0.06
(0.35)
Number of gingival events
0.00
(0.00)
0.01
(0.11)
0.01
(0.11)
0.03
(0.25)
Number of nasal events
0.00
(0.00)
0.00
(0.00)
0.07
(0.36)
0.08
(0.37)
Number of pulmonary events
0.00
(0.00)
0.00
(0.00)
0.02
(0.19)
0.02
(0.12)
Number of articular-muscular events
0.01
(0.10)
0.00
(0.00)
0.02
(0.19)
0.00
(0.00)
Number of conjunctival events
0.00
(0.00)
0.04
(0.20)
0.01
(0.08)
0.02
(0.12)
37. Secondary Outcome
Title CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Mean (Standard Deviation) [score on a scale]
4.05
(1.34)
4.43
(1.33)
4.63
(1.36)
4.32
(1.28)
38. Secondary Outcome
Title Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke: Low risk (score 0 in male; score 1 in female) Moderate risk (score 1 in male; score 2 in female) High risk (score ≥2 in male; score ≥3 in female)
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Low risk
0
0%
0
0%
0
0%
0
0%
Moderate risk
0
0%
0
0%
0
0%
0
0%
High risk
192
100%
76
100%
166
100%
66
100%
39. Secondary Outcome
Title HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Mean (Standard Deviation) [score on a scale]
1.99
(0.82)
1.64
(0.78)
2.01
(0.92)
2.06
(0.93)
40. Secondary Outcome
Title Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk: Low risk (score 0) Intermediate risk (score 1-2) High risk (score ≥3)
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Low risk
0
0%
0
0%
0
0%
0
0%
Intermediate risk
147
76.6%
64
84.2%
118
71.1%
48
72.7%
High risk
45
23.4%
12
15.8%
48
28.9%
18
27.3%
41. Secondary Outcome
Title Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type
Description Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported. The concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following: Angiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor Beta-blocker Calcium channel blockers Diuretics Amiodarone Statin Proton pump inhibitor H2-receptor antagonist Digoxin NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) Dronedarone Ketoconazole Cyclosporine Itraconazole Other antiarrhythmics
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
No
0
0%
0
0%
0
0%
0
0%
Yes
192
100%
76
100%
166
100%
66
100%
No
54
28.1%
20
26.3%
57
34.3%
18
27.3%
Yes
138
71.9%
56
73.7%
109
65.7%
48
72.7%
No
82
42.7%
27
35.5%
54
32.5%
21
31.8%
Yes
110
57.3%
49
64.5%
112
67.5%
45
68.2%
No
154
80.2%
53
69.7%
136
81.9%
47
71.2%
Yes
38
19.8%
23
30.3%
30
18.1%
19
28.8%
No
87
45.3%
32
42.1%
56
33.7%
19
28.8%
Yes
105
54.7%
44
57.9%
110
66.3%
47
71.2%
No
174
90.6%
67
88.2%
146
88%
62
93.9%
Yes
18
9.4%
9
11.8%
20
12%
4
6.1%
No
83
43.2%
34
44.7%
77
46.4%
18
27.3%
Yes
109
56.8%
42
55.3%
89
53.6%
48
72.7%
No
89
46.4%
29
38.2%
58
34.9%
17
25.8%
Yes
103
53.6%
47
61.8%
108
65.1%
49
74.2%
No
191
99.5%
75
98.7%
162
97.6%
65
98.5%
Yes
1
0.5%
1
1.3%
4
2.4%
1
1.5%
No
168
87.5%
71
93.4%
153
92.2%
57
86.4%
Yes
24
12.5%
5
6.6%
13
7.8%
9
13.6%
No
180
93.8%
72
94.7%
155
93.4%
61
92.4%
Yes
12
6.3%
4
5.3%
11
6.6%
5
7.6%
No
192
100%
76
100%
163
98.2%
66
100%
Yes
0
0%
0
0%
3
1.8%
0
0%
No
192
100%
76
100%
166
100%
66
100%
Yes
0
0%
0
0%
0
0%
0
0%
No
192
100%
76
100%
166
100%
66
100%
Yes
0
0%
0
0%
0
0%
0
0%
No
192
100%
76
100%
166
100%
66
100%
Yes
0
0%
0
0%
0
0%
0
0%
No
188
97.9%
73
96.1%
160
96.4%
65
98.5%
Yes
4
2.1%
3
3.9%
6
3.6%
1
1.5%
42. Secondary Outcome
Title Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Description Number of patients in each category of previous Vitamin K Antagonists (VKA) treatment according to duration since the first non-vitamin K antagonist oral anticoagulant (NOAC) initiation is reported. Previous VKA treatment was categorized in 2 categories: No; Yes.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC)>4 months.
Measure Participants 39 461
No
26
13.5%
187
246.1%
Yes
13
6.8%
274
360.5%
43. Secondary Outcome
Title Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation
Description Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who previously received VKA treatment. One patient received acenocoumarol and warfarin during the study, so the total percentage is not 100%.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 13 274
Acenocoumarol
13
6.8%
263
346.1%
Warfarin
0
0%
12
15.8%
44. Secondary Outcome
Title Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Description Duration of treatment (in years) is reported for: All patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA) Patients treated only with the VKA warfarin (row: Warfarin patients) Patients treated only with the VKA acenocoumarol (row: Acenocoumarol patients)
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 13 274
Acenocoumarol patients
3.65
(3.85)
3.88
(4.14)
Warfarin patients
3.35
(1.94)
All patients treated previously with VKA
3.65
(3.85)
3.87
(4.07)
45. Secondary Outcome
Title Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation
Description Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for: All patients Patients treated previously with VKA Patients treated only with NOAC as anticoagulant (AC)
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 460
All patients
1.62
(2.77)
3.27
(4.95)
Patients treated previously with VKA
3.71
(3.70)
4.84
(4.79)
Patients treated with NOAC as first AC
0.58
(1.30)
0.99
(4.27)
46. Secondary Outcome
Title First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation
Description Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
First NOAC received: Dabigatran ( 110 mg BID and 150 mg BID patients)
23
12%
174
228.9%
First NOAC received: Rivaroxaban (15 mg QD and 20 mg QD patients)
2
1%
81
106.6%
First NOAC received: Apixaban (2.5 mg BID and 5 mg BID patients)
9
4.7%
143
188.2%
First NOAC received: Edoxaban (30 mg QD and 60 mg QD patients)
5
2.6%
63
82.9%
First NOAC dose: Dabigatran 110 mg BID
6
3.1%
88
115.8%
First NOAC dose: Dabigatran 150 mg BID
17
8.9%
86
113.2%
First NOAC dose: Rivaroxaban 15 mg QD
0
0%
30
39.5%
First NOAC dose: Rivaroxaban 20 mg QD
2
1%
51
67.1%
First NOAC dose: Apixaban 2.5 mg BID
4
2.1%
53
69.7%
First NOAC dose: Apixaban 5 mg BID
5
2.6%
90
118.4%
First NOAC dose: Edoxaban 30 mg QD
4
2.1%
26
34.2%
First NOAC dose: Edoxaban 60 mg QD
1
0.5%
37
48.7%
47. Secondary Outcome
Title Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Description Number of patients who changed (increased and decreased) and did not change the first non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months.
Measure Participants 39 461
No
39
20.3%
427
561.8%
Yes (increase)
0
0%
8
10.5%
Yes (decrease)
0
0%
26
34.2%
48. Secondary Outcome
Title First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
Description Treatment duration (in years) is reported for: Patients who stopped first NOAC treatment; Patients who did not stop the first NOAC treatment.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
Patients who stopped first NOAC treatment
0.01
1.60
(1.61)
Patients who did not stop the first NOAC treatment
0.30
(0.03)
2.38
(1.93)
49. Secondary Outcome
Title Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Description Reason for first NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Only patients who stopped first NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 1 42
Lack of effectiveness
0
0%
1
1.3%
Investigator's decision
0
0%
15
19.7%
Patient's decision
0
0%
7
9.2%
Adverse event
1
0.5%
19
25%
50. Secondary Outcome
Title Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Description Reason for first NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Only patients who changed dose in first NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 34
Lack of effectiveness
2
1%
Investigator's decision
24
12.5%
Patient's decision
0
0%
Adverse event
8
4.2%
51. Secondary Outcome
Title Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
Description Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
Mean (Standard Deviation) [switches per patient]
0.03
(0.16)
0.10
(0.35)
52. Secondary Outcome
Title Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation
Description Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported. Number of switches to a new NOAC was categorized in 3 categories: 0 switches 1 switch 2 switches.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
0 switches
38
19.8%
419
551.3%
1 switch
1
0.5%
36
47.4%
2 switches
0
0%
6
7.9%
53. Secondary Outcome
Title Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Description Total number of switches according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who switched to a new NOAC.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 1 48
Dabigatran to Rivaroxaban
0
3
Dabigatran to Apixaban
0
9
Dabigatran to Edoxaban
0
2
Rivaroxaban to Dabigatran
0
0
Rivaroxaban to Apixaban
1
10
Rivaroxaban to Edoxaban
0
2
Apixaban to Dabigatran
0
5
Apixaban to Rivaroxaban
0
3
Apixaban to Edoxaban
0
4
Edoxaban to Dabigatran
0
4
Edoxaban to Rivaroxaban
0
0
Edoxaban to Apixaban
0
6
54. Secondary Outcome
Title Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Description Reason for switch was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who switched to a new NOAC.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 1 48
Lack of effectiveness
0
1
Investigator's decision
0
17
Patient's decision
0
7
Adverse event
1
23
55. Secondary Outcome
Title Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation
Description Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Number of patients who stopped the first NOAC treatment and switched to a second NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 1 42
Second NOAC received: Dabigatran (110 mg BID and 150 mg BID patients)
0
0%
8
10.5%
Second NOAC received: Rivaroxaban (15 mg QD and 20 mg QD patients)
0
0%
5
6.6%
Second NOAC received: Apixaban (2.5 mg BID and 5 mg BID patients)
1
0.5%
21
27.6%
Second NOAC received: Edoxaban (30 mg QD and 60 mg QD patients)
0
0%
8
10.5%
Second NOAC dose: Dabigatran 110 mg BID
6
3.1%
Second NOAC dose: Dabigatran 150 mg BID
2
1%
Second NOAC dose: Rivaroxaban 15 mg QD
3
1.6%
Second NOAC dose: Rivaroxaban 20 mg QD
2
1%
Second NOAC dose: Apixaban 2.5 mg BID
0
0%
13
17.1%
Second NOAC dose: Apixaban 5 mg BID
1
0.5%
8
10.5%
Second NOAC dose: Edoxaban 30 mg QD
3
1.6%
Second NOAC dose: Edoxaban 60 mg QD
5
2.6%
56. Secondary Outcome
Title Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Description Number of patients who changed (increased or decreased) and did not change the second non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who stopped the first NOAC treatment and switched to a second NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 1 42
No
1
0.5%
40
52.6%
Yes (increase)
0
0%
1
1.3%
Yes (decrease)
0
0%
1
1.3%
57. Secondary Outcome
Title Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
Description Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who stopped second NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months..
Measure Participants 0 6
Mean (Standard Deviation) [Years]
0.49
(0.39)
58. Secondary Outcome
Title Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Description Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who stopped second NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 6
Lack of effectiveness
0
0%
Investigator's decision
2
1%
Patient's decision
0
0%
Adverse event
4
2.1%
59. Secondary Outcome
Title Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Description Reason for second NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who changed dose in second NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 2
Lack of effectiveness
0
0%
Investigator's decision
2
1%
Patient's decision
0
0%
Adverse event
0
0%
60. Secondary Outcome
Title Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation
Description Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who stopped second NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 6
Third NOAC received: Dabigatran
1
0.5%
Third NOAC received: Rivaroxaban
1
0.5%
Third NOAC received: Apixaban
4
2.1%
Third NOAC received:Edoxaban
0
0%
Third NOAC dose: Dabigatran 110 mg BID
1
0.5%
Third NOAC dose: Dabigatran 150 mg BID
0
0%
Third NOAC dose: Rivaroxaban 15 mg QD
1
0.5%
Third NOAC dose: Rivaroxaban 20 mg QD
0
0%
Third NOAC dose: Apixaban 2.5 mg BID
3
1.6%
Third NOAC dose: Apixaban 5 mg BID
1
0.5%
61. Secondary Outcome
Title Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation
Description Number of patients who changed (increased and decreased) and did not change the third non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who started third NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 6
No
6
3.1%
Yes (increase)
0
0%
Yes (decrease)
0
0%
62. Secondary Outcome
Title Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation
Description Duration of third NOAC treatment for patients who stopped NOAC treatment.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 0
63. Secondary Outcome
Title Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation
Description Reason for Third NOAC treatment discontinuation was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 0
Lack of effectiveness
Investigator's decision
Patient's decision
Adverse event
64. Secondary Outcome
Title Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation
Description Reason for Third NOAC treatment change was categorized in four categories: Lack of effectiveness Investigator's decision Patient's decision Adverse event
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Participants of FAS who changed dose in third NOAC treatment. No patients stopped the third NOAC treatment.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 0 0
Lack of effectiveness
Investigator's decision
Patient's decision
Adverse event
65. Secondary Outcome
Title Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
Description Duration (in years) in NOAC treatment is reported for: All patients (patients who received or did not receive VKA) Patients treated previously with Vitamin K Antagonists (VKA) Patients treated with NOAC as first anticoagulant
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
All patients
0.29
(0.03)
2.45
(1.96)
Patients treated previously with VKA
0.29
(0.03)
2.39
(1.98)
Patients treated with NOAC as first anticoagulant
0.29
(0.03)
2.54
(1.94)
66. Secondary Outcome
Title Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation
Description Number of patients in each category of total time in non-vitamin K antagonist oral anticoagulant (NOAC) treatment according to duration since the first NOAC initiation is reported. Total time in NOAC treatment was categorized in 4 categories: <1 year; 1-2 years; 2-3 years; >3 years.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
<1 year
39
20.3%
149
196.1%
1-2 years
0
0%
87
114.5%
2-3 years
0
0%
74
97.4%
>3 years
0
0%
151
198.7%
67. Secondary Outcome
Title Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Description Number of patients for each type of following antiplatelet treatment that the patients ever received is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned).
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
None (no antiplatelet treatment received)
35
18.2%
314
413.2%
Acetyl salicylic acid
4
2.1%
124
163.2%
Clopidogrel
1
0.5%
43
56.6%
Prasugrel
0
0%
2
2.6%
Ticlopidine
0
0%
1
1.3%
Ticagrelor
0
0%
1
1.3%
Cilostazol
0
0%
0
0%
Triflusal
0
0%
3
3.9%
Dipyridamole
0
0%
0
0%
Others (other antiplatelet treatment than listed above)
0
0%
0
0%
68. Secondary Outcome
Title Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation
Description Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported: None (reports the patients who did not receive any antiplatelet treatment) Acetyl salicylic acid Clopidogrel Prasugrel Ticlopidine Ticagrelor Cilostazol Triflusal Dipyridamole Others (other antiplatelet treatment than above mentioned).
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
None
38
19.8%
444
584.2%
Acetyl salicylic acid
0
0%
9
11.8%
Clopidogrel
1
0.5%
11
14.5%
Prasugrel
0
0%
0
0%
Ticlopidine
0
0%
0
0%
Ticagrelor
0
0%
1
1.3%
Cilostazol
0
0%
0
0%
Triflusal
0
0%
3
3.9%
Dipyridamole
0
0%
0
0%
Others
0
0%
0
0%
69. Secondary Outcome
Title Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation
Description Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title ≤4 Months >4 Months
Arm/Group Description All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.
Measure Participants 39 461
Mean (Standard Deviation) [Years]
5.82
(1.66)
5.98
(7.06)
70. Secondary Outcome
Title Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score >4 was considered frail.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
1-Very fit
11
5.7%
6
7.9%
8
4.8%
0
0%
2-Well
24
12.5%
15
19.7%
18
10.8%
9
13.6%
3-Managing well
79
41.1%
23
30.3%
44
26.5%
24
36.4%
4-Vulnerable
45
23.4%
11
14.5%
46
27.7%
19
28.8%
5-Mildly frail
13
6.8%
8
10.5%
16
9.6%
7
10.6%
6-Moderately frail
15
7.8%
10
13.2%
24
14.5%
3
4.5%
7-Severely frail
4
2.1%
3
3.9%
9
5.4%
3
4.5%
8-Very severely frail
1
0.5%
0
0%
1
0.6%
1
1.5%
9-Terminally ill
0
0%
0
0%
0
0%
0
0%
71. Secondary Outcome
Title Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type
Description Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. CFS was categorized in two categories, according to this ranges: Frailty patients - CFS scoring >4 Non-frailty patients - CFS scoring ≤4
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 192 76 166 66
Non-frailty patients (CFS scoring ≤4)
159
82.8%
55
72.4%
116
69.9%
52
78.8%
Frailty patients (CFS scoring >4)
33
17.2%
21
27.6%
50
30.1%
14
21.2%
72. Secondary Outcome
Title Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type
Description Reason for First NOAC usage was categorized in the following two categories: Primary prevention; Secondary prevention.
Time Frame At the single study visit (Day 1).

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis.
Arm/Group Title Dabigatran Rivaroxaban Apixaban Edoxaban
Arm/Group Description Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Apixaban (either were receiving 2.5 milligram (mg) apixaban twice daily (BID) or 5 mg apixaban BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. Patients in this arm were on treatment with Edoxaban (either were receiving 30 milligram (mg) edoxaban once daily (QD) or 60 mg edoxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit.
Measure Participants 190 75 166 66
Primary prevention
138
71.9%
61
80.3%
135
81.3%
54
81.8%
Secondary prevention
52
27.1%
14
18.4%
31
18.7%
12
18.2%

Adverse Events

Time Frame Information about the adverse events (AEs) was collected from the patients' medical records at the time of single study visit (Day 1). AEs collection covered a total time of 10 years.
Adverse Event Reporting Description Adverse events were collected and reported only for patients who received dabigatran either as first NOAC, or second NOAC or third NOAC.For rivaroxaban, apixaban and edoxaban patients' adverse events were not assessed.
Arm/Group Title All Dabigatran Patients
Arm/Group Description This group included all patients who received dabigatran either as first NOAC (patients who the first NOAC prescribed was dabigatran), or as second NOAC (patients who stopped the first prescribed NOAC and received dabigatran as second NOAC), or as third NOAC (patients who stopped the second prescribed NOAC and received dabigatran as third NOAC).
All Cause Mortality
All Dabigatran Patients
Affected / at Risk (%) # Events
Total 0/206 (0%)
Serious Adverse Events
All Dabigatran Patients
Affected / at Risk (%) # Events
Total 4/206 (1.9%)
Gastrointestinal disorders
Gastrointestinal haemorrhage 1/206 (0.5%)
Intestinal haemorrhage 1/206 (0.5%)
Lower gastrointestinal haemorrhage 1/206 (0.5%)
Nervous system disorders
Transient ischaemic attack 1/206 (0.5%)
Other (Not Including Serious) Adverse Events
All Dabigatran Patients
Affected / at Risk (%) # Events
Total 0/206 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.

Results Point of Contact

Name/Title Boehringer Ingelheim, Call Center
Organization Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03993119
Other Study ID Numbers:
  • 1160-0297
First Posted:
Jun 20, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021