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Bayer initiates Rivaroxaban Phase III study



Bayer HealthCare has announced the initiation of EINSTEIN CHOICE, a Phase III clinical trial that will evaluate two doses of its once-daily novel oral anticoagulant rivaroxaban (Xarelto®) against acetylsalicylic acid (ASA) for the long-term, secondary prevention of symptomatic venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). 
The study supplements the EINSTEIN Trial Programme, which established in the EINSTEIN Extension study that rivaroxaban 20mg once daily delivers a significant reduction in the risk of long-term prevention of recurrent symptomatic DVT and PE in patients who previously completed six or 12 months of anticoagulation treatment. EINSTEIN CHOICE will include approximately 2,850 patients at 250 centres in 30 countries worldwide, and will evaluate whether once-daily rivaroxaban in doses of 10mg or 20mg is superior to ASA at 100mg in the prevention of fatal or non-fatal symptomatic recurrent venous thromboembolism, in patients who have completed between six and 12 months of anticoagulant treatment for their index DVT or PE event.
If anticoagulant therapy is stopped after six to 12 months in patients with unprovoked venous thromboembolism, the risk of recurrence is about 10% at one year. Nonetheless, many physicians stop warfarin treatment after six months and may switch patients to aspirin because of the inconvenience of warfarin management and fears about the risk of bleeding,” said Jeffrey Weitz, Professor and Deputy Chair Research, Department of Medicine, McMaster University, and Executive Director of the Thrombosis and Atherosclerosis Research Institute, Hamilton, Canada and Co-Chair of the EINSTEIN CHOICE Steering Committee. “The EINSTEIN CHOICE study is designed to inform us as to whether reducing the dose of rivaroxaban from 20 mg once daily to 10 mg once daily maintains efficacy and lowers the risk of bleeding, and whether both doses of rivaroxaban are better than aspirin at reducing the risk of recurrence. Therefore, the results of this study may enable alignment of anticoagulant treatment with the benefit-risk profile of the individual patient.”
“Bayer remains committed to providing the best possible understanding of the clinical utility of Xarelto, as real-world experience of its use grows across a broad range of venous and arterial thromboembolic disorders,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “This study is a key part of that commitment and our ever-growing clinical trial programme that continues to make Xarelto the most widely studied novel oral anticoagulant.”

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