Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
|ClinicalTrials.gov Identifier: NCT02433366|
Recruitment Status : Completed
First Posted : May 5, 2015
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1213 participants|
|Official Title:||Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF|
|Study Start Date :||January 2015|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
- Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) [ Time Frame: Day 1 ]
The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.
This Outcome measure is applicable only for the Physicians group.
- 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) [ Time Frame: Day 1 ]The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433366
Show 161 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|