N/A
Completed N=1,213
Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
Source: ClinicalTrials.gov NCT02433366 ↗Enrolled (actual)
1,213
Serious AEs
—
Results posted
Sep 2016
Primary outcomePrimary: Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) — 65; 71; 95; 100 Percentage of Participants
Summary
The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) |
65; 71; 95; 100 | — |
| PRIMARY Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) |
55; 83; 100; 89; 54; 52 | — |
Eligibility Criteria
Inclusion criteria
- Pradaxa® prescribers (cardiologists and primary care physicians)
- Patients with atrial fibrillation treated with Pradaxa®
Exclusion criteria
As defined in Summary of Product Characteristics for patients treated with Pradaxa®
Data sourced from ClinicalTrials.gov (NCT02433366). 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.