The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
- Warfarin (Coumadin®)Drug
Intervention Desc: once a day ARM 1: Kind: Experimental Label: Warfarin Description: once a day
- Dabigatran (Pradaxa)Drug
Other Names: Pradax (Canada)/ Pradaxa (USA and rest of world) Intervention Desc: Dabigatran is an anticoagulant from the class of the direct thrombin inhibitors. It is being studied for various clinical indications, for some of which it may replace warfarin as the preferred anticoagulant. It is orally administered as the prodrug dabigatran etexilate.
- Dabigatran dose 2 Drug
Intervention Desc: twice a day ARM 1: Kind: Experimental Label: Dabigatran dose 2 Description: twice a day
- Dabigatran dose 1 Drug
Intervention Desc: twice daily ARM 1: Kind: Experimental Label: Dabigatran dose 1 Description: twice a day
- Allocation: Randomized
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Active participation in BrainPort training sessions with a Physical Therapist for two 1-hour sessions daily for 5 consecutive days in the clinic, followed by training for 2-20 minute sessions each day at home for 7 weeks. Assessments completed at baseline, 5 days and at end of study (8 weeks).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Incidence of stroke (including hemorrhagic) and systemic embolism.|
|Secondary||Incidence of stroke (including hemorrhagic), systemic embolism, all death Incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, or vascular deaths (including deaths from bleeding)|
|Primary||Yearly Event Rate for Composite Endpoint of Stroke/SEE||36 months||No|
|Secondary||Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death||36 months||No|
|Secondary||Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death||36 months||No|
|Secondary||Bleeding Events (Major and Minor)||36 months||Yes|
|Secondary||Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)||36 months||No|
|Secondary||Abnormal Liver Function Test||36 months||No|