The SPORTIF V (Stroke Prevention using an ORal Direct Thrombin Inhibitor in Patients with Atrial Fibrillation) trial, the largest stroke prevention trial ever conducted in patients with atrial fibrillation, was designed to evaluate whether fixed oral-dose ximelagatran (36 mg twice daily) is as effective as well-controlled warfarin (dose-adjusted to a standard level of anticoagulation intensity, INR 2-3) in preventing all strokes and systemic embolic events. Results showed that patients treated with ximelagatran (n=1,960) had a 1.6 percent per year chance of having a stroke or systemic embolic event (51 events), compared to a 1.2 percent chance for 1,962 patients treated with warfarin (37 events). Those receiving ximelagatran experienced a 4.2 percent per year rate of death, stroke, systemic embolic events and acute myocardial infarction (110 events), compared to 4.4 percent (121 events) for patients on warfarin. The SPORTIF V study was double-blind, involving 3,922 patients in the U.S and Canada who also had one or more stroke risk factors in addition to AF (age 75 or older, prior stroke or blood clot, a history of congestive heart failure or hypertension or certain combinations of advanced age and diabetes or coronary artery disease). The research was sponsored by AstraZeneca PLC, which is developing ximelagatran under the trade name EXANTA. Ximelagatran is currently approved for short-term use in some European countries, but it has not been approved in the United States.
"The SPORTIF data indicate a solid clinical benefit to ximelagatran, and publica
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8-Feb-2005