New Phase III study of Lixiana in Stroke Prevention (AF) - Daiichi Sankyo
Daiichi Sankyo has announced that it has started enrolling patients into the ENSURE-AF multinational Phase III study, which will evaluate the efficacy and safety of Lixiana (edoxaban) compared to enoxaparin/warfarin for the prevention of Stroke and other blood clot complications in patients with non-valvular Atrial Fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm).
More than 2,200 patients are expected to be enrolled in ENSURE-AF at approximately 250 clinical sites across North America and Europe. Patients will be randomized to receive edoxaban 60 mg (or a patient specific dose of edoxaban 30 mg for patients with renal impairment or low body weight or p-glycoprotein inhibitor use) or enoxaparin/warfarin for 28-49 days. The drug was filed in the US and EU in January 2014.
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