Bristol-Myers, Pfizer Report First Patient Enrollment In Phase IV EMANATE Trial

(RTTNews) - Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) announced that the first patient has been enrolled into a Phase IV study, called EMANATE, evaluating the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation or NVAF undergoing cardioversion.

Currently, Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with NVAF. Cardioversion is a commonly used, effective method of converting atrial fibrillation to a normal rhythm, allowing the heart to pump more effectively. Traditionally, anticoagulation is administered for a minimum of 3 weeks earlier to cardioversion and for four weeks afterward.

EMANATE, a randomized, open-label trial, would assess the effectiveness and safety of Eliquis compared with usual care initiated in patients with NVAF expected to undergo cardioversion after short-term anticoagulation, in a clinical practice setting. In NVAF patients presenting at least 48 hours after the onset of NVAF, early cardioversion would be performed after the exclusion of a thrombus by imaging, on the same day or within a few days. In NVAF patients presenting within 48 hours of the onset of NVAF, cardioversion would be performed promptly without prior imaging. In all patients, Eliquis or usual care would be initiated prior to cardioversion and continued for up to 30 days post-cardioversion.

The EMANATE trial is expected to enroll 1,500 eligible patients from the U.S., Canada, Europe and Asia. Patients would be randomized 1:1 to Eliquis or usual care, to be administered for up to 30 days following early cardioversion or 90 days post randomization if cardioversion is not performed within this timeframe.

The primary efficacy endpoints are the occurrence of acute stroke, systemic embolism and all-cause death; while the primary safety endpoints are major bleeding and clinically relevant non-major bleeding.