The primary efficacy end point was achieved in 53 (53.0%) of 100, 58 (59.2%) of 98, 62 (56.9%) of 109, and 49 (43.8%) of 112 patients receiving rivaroxaban 10, 20, or 30 mg BID or 40 mg once daily, respectively, compared with 50 (45.9%) of 109 patients treated with enoxaparin/vitamin K antagonist. Outcomes were adjudicated centrally without knowledge of treatment allocation. The primary safety end point was major bleeding during 12 weeks of treatment. The primary efficacy end point was an improvement in thrombotic burden at day 21 (assessed by quantitative compression ultrasonography ≥4-point improvement in thrombus score) without recurrent symptomatic venous thromboembolism or venous thromboembolism-related death. Each treatment was administered for 12 weeks. Methods and Results- This randomized, parallel-group phase II trial in patients with proximal deep-vein thrombosis explored the efficacy and safety of rivaroxaban 10, 20, or 30 mg BID or 40 mg once daily compared with enoxaparin 1 mg/kg BID followed by vitamin K antagonist.

Rivaroxaban (BAY 59-7939) is an oral direct factor Xa inhibitor currently under clinical development. Customer Service and Ordering Informationīackground- An effective and safe oral anticoagulant that needs no monitoring for dose adjustment is urgently needed for the treatment of diseases that require long-term anticoagulation.

Stroke: Vascular and Interventional Neurology.

Journal of the American Heart Association (JAHA).

Circ: Cardiovascular Quality & Outcomes.

Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB).

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