Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,852
- Locations
- 148
- Primary Endpoint
- Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Study Overview
Brief Summary
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Time Frame: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Time Frame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.
Patient Characterization at Baseline - Categorical Parameters
Time Frame: Baseline
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
Time Frame: Baseline
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. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
Time Frame: Baseline
Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.
Patient Characterization at Baseline - Creatinine Clearance
Time Frame: Baseline
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Secondary Outcomes
- Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment(Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).)
- Description of PACT-Q1 Items for Patients in Cohort B at Baseline(Baseline)