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The oral direct thrombin inhibitor ximelagatran is being studied intensely as a potential substitute for warfarin. Ximelagatran -- which is not yet FDA-approved -- is given in a fixed dose and does not require coagulation monitoring. In 2 international, industry-sponsored, double-blind trials, researchers examined the efficacy of ximelagatran to prevent venous thromboembolism.
In one study, 2301 patients who were scheduled for total knee replacement were randomized to receive ximelagatran (36 mg or 24 mg twice daily) or warfarin (target INR, 2.5), starting shortly after surgery and continuing for 7 to 12 days until patients underwent leg venography. The frequency of the primary endpoint (death or any venous thromboembolism) was 20% with 36-m…