RE-QUOL: Health-related Quality of Life in Patients on Anticoagulants
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03134911
Collaborator
(none)
535
39
9.3
13.7
1.5
Study Details
Study Description
Brief Summary
The present study has been designed to describe the health-related quality of life in patients with non valvular atrial fibrillation who have been prescribed a specific anticoagulant treatment for their non valvular atrial fibrilation at least 6 months prior to study initiation. It will be conducted in Departments of Internal Medicine from approximately 50 centers in Spain. It consists of an only visit that will coincide with one of those performed by the patients as part of routine follow-up of their disease. 500 patients seen in internal medicine are planned to be included in the study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
535 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Non-Interventional, Cross-sectional Study to Describe Health-related Quality of Life Among Controlled and Uncontrolled Patients With Nonvalvular Atrial Fibrillation on Anticoagulants. RE-QUOL Study.
Actual Study Start Date
:
Apr 24, 2017
Actual Primary Completion Date
:
Jan 31, 2018
Actual Study Completion Date
:
Jan 31, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| anticoagulation controlled patients Treated with DOAC or VKA |
Drug: DOAC or VKA
6 months - 2 years
|
| anticoagulation non controlled patients Treated with VKA |
Drug: VKA
6 months - 2 years
|
Outcome Measures
Primary Outcome Measures
- Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire [The study consisted of a single visit between April 2017 and January 2018]
Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score.
Secondary Outcome Measures
- Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Age group, work status and life status of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
- Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
- Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
- Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
- Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Kidney function of uncontrolled non-valvular atrial fibrillation (NVAF) patients measured by creatinine clearance is presented.
- History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis [The study consisted of a single visit between April 2017 and January 2018]
Analysis of data regarding the specific NVAF profile of uncontrolled patients indicated that the average (± SD) time since diagnosis (calculated as the time from the date of diagnosis to the date of the baseline visit).
- History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis [The study consisted of a single visit between April 2017 and January 2018]
Age at diagnosis of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
- Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Left ventricular ejection fraction (LVEF) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
- Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Percentage of patients with left ventricular ejection fraction (LVEF) depression (% of LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively.
- CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
- HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
- Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories [The study consisted of a single visit between April 2017 and January 2018]
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of thromboembolic events by categories are presented.
- Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories [The study consisted of a single visit between April 2017 and January 2018]
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of haemorrhagic events by categories are presented.
- Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Number of visits to the internal medicine specialist per year of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.
- Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Therapeutic time in range (TTR%) of uncontrolled non-valvular atrial fibrillation (NVAF) patients determined by the Rosendaal method (poor control < 65%) or by the direct method (poor control < 60%).
- Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients [The study consisted of a single visit between April 2017 and January 2018]
Time since treatment initiation of uncontrolled non-valvular atrial fibrillation (NVAF) patients was calculated as the time from the start date of treatment to the date of the baseline visit.
- Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment [The study consisted of a single visit between April 2017 and January 2018]
Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients received type VKA treatment is presented.
- The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases [The study consisted of a single visit between April 2017 and January 2018]
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with at least one other concomitant diseases recorded in the medical history.
- The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day [The study consisted of a single visit between April 2017 and January 2018]
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with active concomitant diseases on visit day. The percentage was calculated on total patients who presented each of the diseases.
- The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment [The study consisted of a single visit between April 2017 and January 2018]
The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with concomitant treatment is presented.
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
-
The patient is on the same anticoagulant therapy (VKA or DOAC) during at least 6 months and maximum 2 years.
-
If treated with VKA, availability of % Time in Therapeutic Range (TTR) in past analytical records or enough amount of International Normalized Ratio (INR) measures to calculate it.
Exclusion Criteria:
-
Current participation in any clinical trial of a drug or device
-
Contraindication to the use of DOAC or VKA as described in the Summary of Product Characteristics (SmPC).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Príncipe de Asturias | Alcalá De Henares (Madrid) | Spain | 28805 | |
| 2 | HospitalUniversitario Príncipe de Asturias | Alcalá De Henares (Madrid) | Spain | 28805 | |
| 3 | Hospita Universitario Fundación Alcorcón | Alcorcón (Madrid) | Spain | 28922 | |
| 4 | Hospital Público Virgen de los Lirios | Alcoy (Alicante) | Spain | 03804 | |
| 5 | Hospital General Universitario de Alicante | Alicante | Spain | 03010 | |
| 6 | Hospital Universitario San Juan de Alicante | Alicante | Spain | 03550 | |
| 7 | Complejo Hospitalario Torrecárdenas | Almería | Spain | 04009 | |
| 8 | Hospital Universitario Monteprincipe | Boadilla Del Monte (Madrid) | Spain | 28660 | |
| 9 | Hospital San Juan de Dios | Bormujos (Sevilla) | Spain | 41930 | |
| 10 | Hospital General Universitario de Castellón | Castellón De La Plana (Castellón) | Spain | 12004 | |
| 11 | Hospital Universitario Reina Sofía | Córdoba | Spain | 14004 | |
| 12 | Hospital General Universitario de Elche | Elche (Alicante) | Spain | 03203 | |
| 13 | Hospital Universitario de Fuenlabrada | Fuenlabrada (Madrid) | Spain | 28942 | |
| 14 | Hospital Comarcal Francesc de Borja | Gandía (València) | Spain | 46702 | |
| 15 | Hospital Universitario Virgen de las Nieves | Granada | Spain | 18014 | |
| 16 | Hospital Universitari Arnau de Vilanova | Lleida | Spain | 25198 | |
| 17 | Hospital De Llíria (depende del Arnau de Vilanova) | Llíria (Valencia) | Spain | 46160 | |
| 18 | Hospital de La Princesa | Madrid | Spain | 28006 | |
| 19 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28007 | |
| 20 | Hopital Clinico San Carlos | Madrid | Spain | 28040 | |
| 21 | Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | 28040 | |
| 22 | Hospital Universitario Doce de Octubre | Madrid | Spain | 28041 | |
| 23 | Hospital Universitario Puerta de Hierro | Majadahonda (Madrid) | Spain | 28222 | |
| 24 | Hospital Costa del Sol | Marbella (Málaga) | Spain | 29603 | |
| 25 | Complejo Hospitalario de Especialidades Virgen de la Victoria | Málaga | Spain | 29010 | |
| 26 | Hospital Regional de Málaga (Carlos Haya) | Málaga | Spain | 29010 | |
| 27 | Hospital Universitario Rey Juan Carlos | Móstoles (Madrid) | Spain | 28933 | |
| 28 | Hospital Universitario de Móstoles | Móstoles (Madrid) | Spain | 28935 | |
| 29 | Hospital Vega Baja | Orihuela (Alicante) | Spain | 03314 | |
| 30 | Hospital Virgen del Camino | Pamplona (Navarra) | Spain | 31008 | |
| 31 | Hospital General de Requena | Requena (Valencia) | Spain | 46340 | |
| 32 | Hospital de Sagunto | Sagunto (Valencia) | Spain | 46520 | |
| 33 | Hospital Universitario Infanta Sofia | San Sebastián De Los Reyes (Madrid) | Spain | 28703 | |
| 34 | Hospital Universitario Virgen Macarena | Sevilla | Spain | 41009 | |
| 35 | Hospital Universitario de Torrevieja | Torrrevieja (Alicante) | Spain | 03186 | |
| 36 | Hospital Clínico Universitariio de Valencia | Valencia | Spain | 46010 | |
| 37 | Consorcio Hospital General Universitario de Valencia | Valencia | Spain | 46014 | |
| 38 | Hospital Universitario de La Plana | Villarreal (Castellón) | Spain | 12540 | |
| 39 | Hospital Lluis Alcanyis | Xàtiva (Valencia) | Spain | 46800 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Mireia Canals, +34607550925, mireia.canals@boehringer-ingelheim.com
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03134911
Other Study ID Numbers:
- 1160-0280
First Posted:
May 1, 2017
Last Update Posted:
Apr 18, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 an observational, multicentre and cross-sectional study conducted in Departments of Internal Medicine from 47 sites in Spain. The patient received the same anticoagulant treatment for at least 6 months and no more than 2 years. |
|---|---|
| Pre-assignment Detail | Data were obtained from a single visit that coincided with one of those performed by the patients as part of routine follow-up of their disease, without interfering with usual clinical practice of the investigator. 535 patients were enrolled and 34 excluded from analysis due to being screening failure and not meeting inclusion/ exclusion criteria. |
| Arm/Group Title | Total Patients With Non-valvular Atrial Fibrillation |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment with uncontrolled anticoagulation status and VKA or direct oral anticoagulant (DOAC) treatment with controlled anticoagulation status were included. For both the groups treatment were given for at least 6 months and up to 2 years. |
| Period Title: Overall Study | |
| STARTED | 535 |
| COMPLETED | 501 |
| NOT COMPLETED | 34 |
Baseline Characteristics
| Arm/Group Title | Uncontrolled Group | Controlled Group | Total |
|---|---|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. | Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group. | Total of all reporting groups |
| Overall Participants | 171 | 330 | 501 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
80.4
(8.7)
|
79.3
(8.8)
|
79.7
(8.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
95
55.6%
|
152
46.1%
|
247
49.3%
|
| Male |
76
44.4%
|
178
53.9%
|
254
50.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
||
| Not Hispanic or Latino |
0
0%
|
||
| Unknown or Not Reported |
0
0%
|
||
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
171
100%
|
330
100%
|
501
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire |
|---|---|
| Description | Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) with uncontrolled anticoagulation status and those with controlled anticoagulation status receiving VKA or direct oral anticoagulant (DOAC) treatment at least 6 months and up to 2 years were included. |
| Arm/Group Title | Controlled Group | Uncontrolled Group |
|---|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) or direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group. | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 330 | 171 |
| Treatment satisfaction |
4.9
(1.0)
|
3.6
(1.3)
|
| Self-efficacy |
4.3
(1.0)
|
3.6
(1.0)
|
| Distress |
3.1
(0.9)
|
3.9
(1.1)
|
| Daily hassles |
2.1
(0.8)
|
3.0
(1.0)
|
| Strained social network |
1.8
(0.9)
|
2.6
(1.2)
|
| Title | Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Age group, work status and life status of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Work status - Employed |
3
1.8%
|
| Work status - Housewife |
40
23.4%
|
| Work status - Retired |
126
73.7%
|
| Work status - Other |
2
1.2%
|
| Life status - Single |
8
4.7%
|
| Life status - Married |
79
46.2%
|
| Life status - Widowed |
78
45.6%
|
| Life status - Divorced |
6
3.5%
|
| Age < 65 |
10
5.8%
|
| Age 65 - 75 |
32
18.7%
|
| Age ≥ 75 |
129
75.4%
|
| Title | Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 142 |
| Mean (Standard Deviation) [Centimeter (cm)] |
163.1
(8.8)
|
| Title | Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 144 |
| Mean (Standard Deviation) [Kilogram (kg)] |
76.5
(16.1)
|
| Title | Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 142 |
| Mean (Standard Deviation) [Kilogram/meter^2 (kg/m^2)] |
28.7
(5.4)
|
| Title | Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Kidney function of uncontrolled non-valvular atrial fibrillation (NVAF) patients measured by creatinine clearance is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 150 |
| Mean (Standard Deviation) [Millilitre/minute (ml/min)] |
57.2
(26.6)
|
| Title | History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis |
|---|---|
| Description | Analysis of data regarding the specific NVAF profile of uncontrolled patients indicated that the average (± SD) time since diagnosis (calculated as the time from the date of diagnosis to the date of the baseline visit). |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Mean (Standard Deviation) [Years] |
2.5
(3.2)
|
| Title | History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis |
|---|---|
| Description | Age at diagnosis of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Mean (Standard Deviation) [Years] |
77.3
(8.7)
|
| Title | Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Left ventricular ejection fraction (LVEF) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 108 |
| Mean (Standard Deviation) [Percentage (%)] |
56.1
(11.2)
|
| Title | Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Percentage of patients with left ventricular ejection fraction (LVEF) depression (% of LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 161 |
| Normal (≥ 50%) |
87.0
|
| Slightly depressed (41-49%) |
3.1
|
| Moderately depressed (31-40%) |
6.2
|
| Severely depressed (≤ 30%) |
3.7
|
| Title | CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Mean (Standard Deviation) [Unit on scale] |
4.5
(1.4)
|
| Title | HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Mean (Standard Deviation) [Unit on scale] |
3.6
(1.1)
|
| Title | Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories |
|---|---|
| Description | Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of thromboembolic events by categories are presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 60 |
| Non-ST segment elevation myocardial infarction |
31.7
|
| Cerebral infarction |
28.3
|
| TIA |
21.7
|
| Pulmonary embolism |
8.3
|
| Stable angina pectoris |
6.7
|
| ST-segment elevation myocardial infarction |
6.7
|
| Unstable angina |
6.7
|
| Deep vein thrombosis |
5.0
|
| Systemic embolism |
1.7
|
| Title | Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories |
|---|---|
| Description | Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of haemorrhagic events by categories are presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 25 |
| Gastrointestinal |
68.0
|
| Genitourinary |
12.0
|
| Pulmonary |
4.0
|
| Articular-muscular |
4.0
|
| Intracranial |
4.0
|
| Conjunctival |
4.0
|
| Nasal |
4.0
|
| Title | Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Number of visits to the internal medicine specialist per year of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Mean (Standard Deviation) [Visits per year] |
3.1
(1.9)
|
| Title | Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Therapeutic time in range (TTR%) of uncontrolled non-valvular atrial fibrillation (NVAF) patients determined by the Rosendaal method (poor control < 65%) or by the direct method (poor control < 60%). |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Rosendaal method (poor control < 65%) |
49.1
(10.8)
|
| The direct method (poor control < 60%) |
35.0
(15.2)
|
| Title | Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients |
|---|---|
| Description | Time since treatment initiation of uncontrolled non-valvular atrial fibrillation (NVAF) patients was calculated as the time from the start date of treatment to the date of the baseline visit. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Mean (Standard Deviation) [Months] |
14.8
(6.3)
|
| Title | Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment |
|---|---|
| Description | Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients received type VKA treatment is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Acenocoumarol |
97.7
(6.3)
|
| Warfarin |
2.3
|
| Title | The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases |
|---|---|
| Description | The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with at least one other concomitant diseases recorded in the medical history. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Hypertension |
85.8
|
| Congestive heart failure |
48.5
|
| Diabetes mellitus |
38.5
|
| Renal failure |
34.3
|
| Anaemia |
32.5
|
| Arterial vascular disease |
19.5
|
| Previous stroke/transient ischaemic attack (TIA) |
17.8
|
| Venous thromboembolism |
4.7
|
| Liver failure |
1.8
|
| Other |
33.1
|
| Title | The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day |
|---|---|
| Description | The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with active concomitant diseases on visit day. The percentage was calculated on total patients who presented each of the diseases. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Hypertension |
72.5
|
| Congestive heart failure |
35.7
|
| Diabetes mellitus |
33.9
|
| Kidney failure |
28.1
|
| Anaemia |
25.1
|
| Arterial vascular disease |
10.5
|
| Previous stroke/TIA |
7.6
|
| Liver failure |
1.2
|
| Venous thromboembolism |
0.6
|
| Other |
23.4
|
| Title | The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment |
|---|---|
| Description | The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with concomitant treatment is presented. |
| Time Frame | The study consisted of a single visit between April 2017 and January 2018 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. |
| Arm/Group Title | Uncontrolled Group |
|---|---|
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. |
| Measure Participants | 171 |
| Yes |
97.1
|
| No |
2.9
|
Adverse Events
| Time Frame | Adverse events collected during the study period between April 2017 and January 2018; up to 41 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Uncontrolled Group | VKA Controlled Group | DOAC Controlled Group | |||
| Arm/Group Description | Patients with non-valvular atrial fibrillation (NVAF) receiving conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with uncontrolled anticoagulation status were included in this group. | Patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group. | Patients with non-valvular atrial fibrillation (NVAF), who received direct oral anticoagulant (DOAC) treatment for at least 6 months and up to 2 years with controlled anticoagulation status, were included in this group. | |||
All Cause Mortality |
||||||
| Uncontrolled Group | VKA Controlled Group | DOAC Controlled Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/171 (0%) | 0/69 (0%) | 0/261 (0%) | |||
Serious Adverse Events |
||||||
| Uncontrolled Group | VKA Controlled Group | DOAC Controlled Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/171 (0%) | 0/69 (0%) | 1/261 (0.4%) | |||
| Gastrointestinal disorders | ||||||
| Upper gastrointestinal haemorrhage | 0/171 (0%) | 0/69 (0%) | 1/261 (0.4%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Uncontrolled Group | VKA Controlled Group | DOAC Controlled Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/171 (0%) | 0/69 (0%) | 0/261 (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 Centre |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03134911
Other Study ID Numbers:
- 1160-0280
First Posted:
May 1, 2017
Last Update Posted:
Apr 18, 2019
Last Verified:
Jan 1, 2019