N/A
Completed N=1,822
Patient Convenience Study
Source: ClinicalTrials.gov NCT02597920 ↗Enrolled (actual)
1,822
Serious AEs
0.8%
Results posted
Feb 2019
Primary outcomePrimary: Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment — 63.4; 77.3; 79.2; 53.8 Units on Scale — p=<0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment |
63.4; 77.3; 79.2; 53.8; 67.7; 70.0 | <0.0001 sig |
| PRIMARY Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups |
78.3; 69.1; 80.3; 69.5; 65.9; 58.0 | 0.0005 sig |
| PRIMARY Patient Characterization at Baseline - Categorical Parameters |
14.2; 17.9; 12.8; 36.4; 36.6; 28.2 | — |
| PRIMARY Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score |
3.4; 3.2; 3.8; 2.1; 1.7; 2.0 | — |
| PRIMARY Patient Characterization at Baseline - Creatinine Clearance |
74.40; 75.89; 63.83 | — |
| PRIMARY Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration |
4.44 | — |
| SECONDARY Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment |
77.3; 79.2; 67.7; 70.0 | <0.0001 sig |
| SECONDARY Description of PACT-Q1 Items for Patients in Cohort B at Baseline |
3.8; 3.7; 3.1; 2.8; 2.7; 2.8 | — |
Eligibility Criteria
Inclusion criteria
Cohort A:
- A. Written informed consent prior to participation
- A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
- A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.
OR
Cohort B:
- B. Written informed consent prior to participation.
- B. Female and male patients >= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
- B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.
Exclusion criteria
- Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
- Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
- Current participation in any clinical trial of a drug or device.
- Current participation in an European registry on the use of oral anticoagulation in AF.
Data sourced from ClinicalTrials.gov (NCT02597920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.