Clinical Trials

Date: 2014-02-17

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Bayer (Germany)

Product: rivaroxaban

Action mechanism:

Disease: long-term, secondary prevention of symptomatic venous thromboembolism( VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE)

Therapeutic area: Cardiovascular diseases

Country:

Trial details:

• The pivotal EINSTEIN Clinical Trial Programme comprises four Phase III studies. EINSTEIN DVT and EINSTEIN PE evaluated rivaroxaban alone (15 mg 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 deep vein thrombosis (DVT) and pulmonary embolism (PE) respectively, and the prevention of recurrent DVT and PE. The EINSTEIN Extension study compared rivaroxaban 20 mg once daily with placebo for the long term prevention of recurrent symptomatic DVT and PE in patients who previously completed 6 or 12 months of anticoagulation treatment with either VKA or rivaroxaban. Now EINSTEIN CHOICE will evaluate the long-term benefit of once-daily rivaroxaban 10 mg and 20 mg to prevent recurrent VTE compared to ASA at 100 mg in patients who have completed between 6 and 12 months of anticoagulant treatment for their index DVT or PE event.

Latest news:

• • On February 17, 2014, 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 20 mg once daily delivers a significant reduction in the risk of long-term prevention of recurrent symptomatic DVT and PE in patients who previously completed 6 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 10 mg or 20 mg is superior to ASA at 100 mg 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.

Is general: Yes