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In patients with nonvalvular atrial fibrillation (NVAF), warfarin anticoagulation limits stroke risk better than aspirin does. Ximelagatran is a new, oral direct thrombin inhibitor (DTI) with consistent pharmacokinetic properties that obviate the needs for dose titration and routine coagulation monitoring that are characteristic of warfarin use. In this European, 12-week safety study, funded by ximelagatran's manufacturer, 254 patients with persistent, verified NVAF and at least 1 stroke risk factor were randomized to 1 of 3 twice-daily doses of ximelagatran (20, 40, or 60 mg) or to dose-adjusted warfarin (target INR, 2.0-3.0).
Adherence to ximelagatran was at least 96% for all 3 doses. No subject suffered a systemic embolic event. Major ble…