RE-CONOCE: This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03285373
• Collaborator: (none)
• Enrollment: 1,008
• Locations: 75
• Actual Duration (Months): 14.1
• Patients Per Site: 13.4
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: NOAC

Study Design

• Study Type: Observational
• Actual Enrollment: 1008 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Non-Interventional, Cross-sectional Study to Describe NOACs Management ss in Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.
• Actual Study Start Date: Nov 29, 2017
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
patients with NVAF patients with Non Valvular Atrial Fibrillation	Drug: NOAC; New Oral Anticoagulant

Outcome Measures

Primary Outcome Measures

1. Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation [Start of the first NOAC treatment]

   Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.

2. Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation [Start of the first NOAC treatment]

   Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The 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.

3. Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation [Start of the first NOAC treatment]

   Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 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)

4. Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation [Start of the first NOAC treatment]

   Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.

5. Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation [Start of the first NOAC treatment]

   Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: Low risk (score 0) Moderate risk (score 1-2) High risk (score ≥3)

Secondary Outcome Measures

1. Appropriateness of NOACs Prescription [single visit (Day 1)]

   Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.

2. Mean Number of Visits to the Physician Per Year [1 year (data collected during single visit on day 1)]

   Mean number of visits to the physician per year considered for the NOAC Management.

3. Duration of First NOAC, All NOAC and Subsequent NOAC Treatment [Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.]

   Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).

4. Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC [single visit (Day 1)]

   Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC

5. Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose [single visit (Day 1)]

   Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.

6. Reason for Treatment Changes [Start of the first NOAC treatment]

   Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.

7. Number of Patients With Previous Treatment With Vitamin K Antagonists [single visit (Day 1)]

   Number of patient with Previous Treatment with Vitamin K Antagonists.

8. Duration of Previous VKA Treatment [Through the observational period with an average of 43.8 months, data collected during a single visit.]

   Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC

9. Patient's Knowledge About His Condition [single visit (Day 1)]

   At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed. Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient is willing and provides written informed consent to participate in this study

• The patient is at least 18 years of age

• The patient has a diagnosis of non-valvular atrial fibrillation (NVAF)

• The patient is on treatment with NOAC according to its approved local SmPC and has initiated his first NOAC starting from November 2016

Exclusion Criteria:

-if the current participating patient participate in any clinical trial of a drug or device will be excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clínica Modelo	A Coruña		Spain	15011
2	Hospital Universatio de Albacete	Albacete		Spain	2006
3	Hospital Quirónsalud Sur	Alcorcón (Madrid)		Spain	28922
4	Hospital General Universitario de Alicante	Alicante		Spain	03010
5	Hospital Dr. José Molina Orosa	Arrecife, Las Palmas		Spain	35500
6	H de Cabueñes	Asturias		Spain	33394
7	Hospital Infanta Cristina	Badajoz		Spain	06080
8	Clínica Sagrada Familia	Barcelona		Spain	08022
9	Medical Practice	Barcelona		Spain	08037
10	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
11	H. del Mar	Barcelona		Spain	8003
12	Hospital del Mar	Barcelona		Spain	8003
13	H. Residencia Sant Camil	Barcelona		Spain	8810
14	H. Moisés Broggi	Barcelona		Spain	8970
15	Hospital Basurto	Bilbao		Spain	48013
16	H Aranda Duero	Burgos		Spain	9400
17	Medical Practice	Castellón		Spain	12540
18	Hospital de Cáceres	Cáceres		Spain	10004
19	Medical Practice	Córdoba		Spain	14005
20	Medical Practice	Córdoba		Spain	14006
21	Centro Médico Puerto	El Puerto De Santa Maria (Cádiz)		Spain	11500
22	Hospital General de Elche	Elche (Alicante)		Spain	03202
23	Hospital Vinalopo Salud	Elche (Alicante)		Spain	03293
24	Hospital García Orcoyen	Estella (Navarra)		Spain	31200
25	Clínica Del Río Estepona y San Pedro	Estepona (Málaga)		Spain	29680
26	Complejo Hospitalario Arquitecto Marcide	Ferrol (A Coruña)		Spain	15405
27	Hospital Galdakao	Galdakao (Vizcaya)		Spain	48960
28	Medical Practice	Gandía (Valencia)		Spain	46702
29	Hospital Vithas La Salud	Granada		Spain	18008
30	Medical Practice	Granada		Spain	18012
31	Medical Practice	Granollers (Barcelona)		Spain	08402
32	H. U. Guadalajara	Guadalajara		Spain	19002
33	Hospital Universitario de Bellvitge	Hospitalet De Ll (Barcelona)		Spain	08907
34	Hospital Juan Ramon Jiménez	Huelva		Spain	21005
35	Medical Practice	Huesca		Spain	22005
36	H. Universitario Dr. Negrín	Las Palmas		Spain	35010
37	Hospital General San Agustin	Linares (Jaen)		Spain	23700
38	Hospital Universitario Lucus Augusti	Lugo		Spain	27003
39	Hospital de la Princesa	Madrid		Spain	28006
40	Hospital Nuestra Señora del Rosario	Madrid		Spain	28006
41	Hospital Gregorio Marañon	Madrid		Spain	28009
42	Hospital Fundación Jiménez Díaz	Madrid		Spain	28040
43	H. Quirón Salud H. Sur Alcorcón	Madrid		Spain	28922
44	Hospital Universitario Puerta del Hierro	Majadahonda (Madrid)		Spain	28222
45	Hospital de Manises	Manises (Valencia)		Spain	36940
46	Hospital Ochoa	Marbella (Málaga)		Spain	29602
47	Hospital de Mataró	Mataró (Barcelona)		Spain	08304
48	Hospital de Mérida	Mérida		Spain	6800
49	Hospital Universitario Central de Asturias	Oviedo (Asturias)		Spain	33011
50	Hospital de Son Llatzer	Palma De Mallorca (Baleares)		Spain	07198
51	Hospital Quirón Campo de Gibraltar	Palmones (Cádiz)		Spain	11379
52	Centro de Especialidades Dr. San Martin	Pamplona		Spain	31004
53	Complejo Hospitalario de Pontevedra	Pontevedra		Spain	36078
54	Hospital Universitari Parc Taulí	Sabadell (Barcelona)		Spain	08208
55	H. C. U. Salamanca	Salamanca		Spain	37007
56	Policlínic Sant Cugat	Sant Cugat Del Valles (Barcelona)		Spain	08172
57	CH Santiago de Compostela	Santiago De Compostela (A Coruña)		Spain	15706
58	Complejo Hospitalario Universitario de Santiago	Santiago De Compostela (A Coruña)		Spain	15706
59	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela (A Coruña)		Spain	15706
60	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
61	Hospital Duque del Infantado	Sevilla		Spain	41012
62	Medical Practice	Sevilla		Spain	41013
63	Hospital Santa Santa Bárbara	Soria		Spain	42005
64	Hospital Universitari de Tarragona Joan XXIII	Tarragona		Spain	43005
65	Hospital Nuestra Señora de la Candelaria	Tenerife		Spain	38010
66	Complejo H. Universitario de Canarias	Tenerife		Spain	38302
67	HM Hospitales Madrid	Torrelodones (Madrid)		Spain	28250
68	Clínica Santa Elena	Torremolinos (Málaga)		Spain	29620
69	Pius Hospital de Valls	Valls (Tarragona)		Spain	43800
70	Hospital Universitari de La Plana	Vila-Real (Castellón)		Spain	12540
71	Hospital Lluis Alcanyis	Xàtiva (Valencia)		Spain	46800
72	Complejo Asistencial de Zamora	Zamora		Spain	49022
73	H. Clínico Universitario	Zaragoza		Spain	50009
74	H. Miguel Servet	Zaragoza		Spain	50009
75	H. Royo Villanova	Zaragoza		Spain	50015

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Mireia Canals, [phone], [e-mail]

Study Documents (Full-Text)

• Study Protocol - Jul 24, 2017
• Statistical Analysis Plan - Apr 1, 2019

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03285373
• Other Study ID Numbers: 1160-0287
• First Posted: Sep 18, 2017
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	Patients with Non Valvular Atrial Fibrillation (NVAF) in Spain, mainly from the hospital setting were on treatment with New Oral Anticoagulant (NOAC) according to its approved local Summary of Product Characteristics (SmPC) and have initiated their first NOAC starting from November 2016 were included in this trial.
Pre-assignment Detail	All patients were screened for eligibility to participate in the trial. Subjects attended specialist sites in Spain to ensure that subjects met all incl/excl criteria. 45 patients (out of 1008 enrolled), did not meet at least one of the selection criteria and were considered not eligible. Data analysis was carried out with 963 eligible patients.

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.
Period Title: Overall Study
STARTED	314	253	266	130
COMPLETED	314	253	266	130
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Overall Participants	963
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	73.6 (10.1)
Sex: Female, Male (Count of Participants)
Female	406 42.2%
Male	557 57.8%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation
Description	Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.
Time Frame	Start of the first NOAC treatment

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	314	253	266	130	963
Mean (Standard Deviation) [Years]	72.8 (9.9)	72.5 (10.7)	72.6 (9.8)	74.0 (10.0)	72.8 (10.1)

2. Primary Outcome

Title	Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
Description	Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation. The 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	Start of the first NOAC treatment

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	308	251	254	129	942
Mean (Standard Deviation) [Unit on Scale]	3.2 (1.5)	3.3 (1.6)	3.3 (1.5)	3.3 (1.5)	3.3 (1.5)

3. Primary Outcome

Title	Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation
Description	Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation. The total CHA2DS2-VASc Scores score was stratified by category according to the following classification: 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	Start of the first NOAC treatment

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	308	251	254	129	942
Low risk	3 0.3%	10 NaN	3 NaN	0 NaN	16 NaN
Moderate risk	53 5.5%	34 NaN	36 NaN	21 NaN	144 NaN
High risk	252 26.2%	207 NaN	215 NaN	108 NaN	782 NaN

4. Primary Outcome

Title	Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation
Description	Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.
Time Frame	Start of the first NOAC treatment

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	308	251	253	128	940
Mean (Standard Deviation) [unit on scale]	1.8 (1.0)	1.8 (1.1)	1.7 (1.1)	1.8 (1.0)	1.8 (1.1)

5. Primary Outcome

Title	Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation
Description	Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation. The total HAS-BLED Score was stratified by category according to the following classification: Low risk (score 0) Moderate risk (score 1-2) High risk (score ≥3)
Time Frame	Start of the first NOAC treatment

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	308	251	253	128	940
Low risk	17 1.8%	29 NaN	27 NaN	11 NaN	84 NaN
Moderate risk	219 22.7%	157 NaN	170 NaN	86 NaN	632 NaN
High risk	72 7.5%	65 NaN	56 NaN	31 NaN	224 NaN

6. Secondary Outcome

Title	Appropriateness of NOACs Prescription
Description	Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met. Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown.
Time Frame	single visit (Day 1)

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	963
Reason 1	88 9.1%
Reason 2	10 1%
Reason 3	16 1.7%
Reason 4	16 1.7%
Reason 5	271 28.1%
Reason 6	102 10.6%
Reason 7	342 35.5%
Reason 8	118 12.3%

7. Secondary Outcome

Title	Mean Number of Visits to the Physician Per Year
Description	Mean number of visits to the physician per year considered for the NOAC Management.
Time Frame	1 year (data collected during single visit on day 1)

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	963
Mean (Standard Deviation) [visits per year]	2.0 (1.1)

8. Secondary Outcome

Title	Duration of First NOAC, All NOAC and Subsequent NOAC Treatment
Description	Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).
Time Frame	Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	963
First NOAC	9.4 (6.5)
All NOAC	9.6 (6.5)
Subsequent NOAC	5.1 (4.1)

9. Secondary Outcome

Title	Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC
Description	Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC
Time Frame	single visit (Day 1)

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	963
Discontinue treatment	4 0.4%
Dose adjustment	20 2.1%
Change to a new NOAC	32 3.3%
No change	907 94.2%

10. Secondary Outcome

Title	Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose
Description	Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.
Time Frame	single visit (Day 1)

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who changed to a new NOAC. As per protocol this endpoint was to be analysed overall for all eligible patients who changed to a new NOAC. Thus, this endpoint was not analysed by NOAC type.

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	32
Dabigatran 110 mg	5 0.5%
Dabigatran 150 mg	4 0.4%
Rivaroxaban 10 mg	1 0.1%
Rivaroxaban 15 mg	2 0.2%
Rivaroxaban 20 mg	4 0.4%
Apixaban 2.5 mg	2 0.2%
Apixaban 5 mg	8 0.8%
Edoxaban 30 mg	2 0.2%
Edoxaban 60 mg	4 0.4%

11. Secondary Outcome

Title	Reason for Treatment Changes
Description	Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.
Time Frame	Start of the first NOAC treatment

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who required treatment changes.As per protocol this endpoint was to be analysed overall for all eligible patients who required treatment changes. Thus, this endpoint was not analysed by NOAC type.

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	56
Lack of efficacy	5 0.5%
Investigator decision	30 3.1%
Patient decision	7 0.7%
Adverse event	14 1.5%

12. Secondary Outcome

Title	Number of Patients With Previous Treatment With Vitamin K Antagonists
Description	Number of patient with Previous Treatment with Vitamin K Antagonists.
Time Frame	single visit (Day 1)

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	314	253	266	130	963
Yes	146 15.2%	125 NaN	100 NaN	53 NaN	424 NaN
No	168 17.4%	128 NaN	166 NaN	77 NaN	539 NaN

13. Secondary Outcome

Title	Duration of Previous VKA Treatment
Description	Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC
Time Frame	Through the observational period with an average of 43.8 months, data collected during a single visit.

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed only for patients with previous VKA treatment (n=424). Dates of start and/or stop of previous VKA treatment were not available for 62 patients.

Arm/Group Title	Dabigatran	Rivaroxaban	Apixaban	Edoxaban	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Rivaroxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Apixaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Edoxaban according to the SmPC.	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	124	107	81	50	362
Mean (Standard Deviation) [Months]	46.6 (52.5)	37.0 (50.6)	54.5 (58.9)	34.0 (47.9)	43.8 (53.2)

14. Secondary Outcome

Title	Patient's Knowledge About His Condition
Description	At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed. Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?
Time Frame	single visit (Day 1)

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.

Arm/Group Title	All Patients
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran, Rivaroxaban, Apixaban or Edoxaban according to the SmPC from November2016 to January2019.
Measure Participants	963
Yes	845 87.7%
No	118 12.3%
Yes	820 85.2%
No	143 14.8%
Yes	766 79.5%
No	197 20.5%
Yes	333 34.6%
No	630 65.4%

Adverse Events

Time Frame	From Informed consent signed until the end of the trial, up to 12 months.
Adverse Event Reporting Description	The study design was of non-interventional nature and the study was conducted within the conditions of the approved marketing authorization. Sufficient data were available to support the evidence on the safety and efficacy of the studied BI drug. For this reason Adverse Drug Reactions (ADR) and fatal Adverse Events (AE) were only collected for one of the NOACs (dabigatran). No data was collected for the other NOACs (Rivaroxaban, Apixaban and Edoxaban) reported on in this study.
Arm/Group Title	Dabigatran
Arm/Group Description	Patients with Non Valvular Atrial Fibrillation (NVAF) started treatment with Dabigatran according to the SmPC.
All Cause Mortality
	Dabigatran
	Affected / at Risk (%)	# Events
Total	1/314 (0.3%)
Serious Adverse Events
	Dabigatran
	Affected / at Risk (%)	# Events
Total	3/314 (1%)
General disorders
Sudden death	1/314 (0.3%)
Nervous system disorders
Ischaemic stroke	1/314 (0.3%)
Cerebrovascular disorder	1/314 (0.3%)
Other (Not Including Serious) Adverse Events
	Dabigatran
	Affected / at Risk (%)	# Events
Total	0/314 (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.