Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
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|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|
|Actual Primary Completion Date :||August 2015|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433366
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|