To compare the safety and efficacy of an oral direct thrombin inhibitor (ximelagatran) with those of warfarin (coumadin) in preventing stroke and systemic embolic events in patients with atrial fibrillation.
- Warfarin (Coumadin®)Drug
Intervention Desc: Anticoagulant (Vitamin K antagonist)
- Ximelagatran (Exanta)Drug
Intervention Desc: Oral anticoagulant. Prodrug is transformed into melagatran, an active site-directed thrombin inhibitor, after gastrointestinal absorption.
Randomized, open-label, parallel-group study, double blind, double-dummy treatment allocation and computerized algorithms to generate sham INR data.
Patients are randomized to receive either ximelagatran or warfarin. Warfarin is dosed to achieve an international normalized ratio (INR) of 2.0 - 3.0. Patients are treated for 12-28 months, during which time they have 15-18 follow-up visits. At each of these visits, blood tests, physical exams and electrocardiograms (EKG's) are performed. INRs will be monitored frequently.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Incidence of stroke and systemic embolic events.|
|Secondary||Stroke, death, TIA, myocardial infarction, major and minor bleeding.|