Bayer HealthCare has started its EINSTEIN CHOICE Phase III clinical study aimed at evaluating 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 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 conducted 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 6 and 12 months of anticoagulant treatment for their index DVT or PE event.
McMaster professor and Deputy Chair Research, Department of Medicine and University EINSTEIN CHOICE Steering Committee co-chair Jeffrey Weitz said: "The EINSTEIN CHOICE study is designed to inform us as to whether reducing the dose of rivaroxaban from 20mg once-daily to 10mg 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."
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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 20mg 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.
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: "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."
Discovered by Bayer HealthCare, rivaroxaban is being jointly developed with Janssen Research & Development.