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news.Bayer HealthCare has initiated a Phase III clinical trial 'EINSTEIN CHOICE' to 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).
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The trial supplements the EINSTEIN Trial Programme, which established in the EINSTEIN Extension study that rivaroxaban 20mg once daily reduces the risk of long-term prevention of recurrent symptomatic DVT and PE in patients who previously completed six or 12 months of anticoagulation treatment.
Around 2,850 patients will be enrolled in the EINSTEIN CHOICE trial, which will be carried out at 250 centres in 30 countries worldwide.
EINSTEIN CHOICE is designed to 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.
The company said that EINSTEIN CHOICE is the last of the EINSTEIN Clinical Trial Programme which includes four Phase III studies.
The EINSTEIN DVT and EINSTEIN PE trials evaluated rivaroxaban alone 15mg twice daily for 21 days followed by 20 mg once daily versus the dual-drug regimen of low molecular weight heparin (LMWH) and a vitamin K antagonist (VKA) in the treatment of DVT and PE respectively, and the prevention of recurrent DVT and PE.
While the EINSTEIN Extension study compared rivaroxaban 20mg once daily with placebo for the long term prevention of recurrent symptomatic DVT and PE in patients who previously completed six or 12 months of anticoagulation treatment with either VKA or rivaroxaban.
Bayer HealthCare member of the executive committee and head of Global Development Joerg Moeller said the company 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.
"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," Moeller added.