Bristol-Myers Squibb and Pfizer Inc. announced that the first patient has been enrolled into a Phase 4 clinical trial called EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF) assessing the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion.
Eliquis is currently approved to reduce the risk of stroke and systemic embolism in patients with NVAF. Cardioversion (administered through electric shock to the chest or with medication) 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 three weeks prior to cardioversion and for four weeks afterward. In some patients, early cardioversion can be performed on the same day or within days of new-onset NVAF, usually after imaging, to confirm the absence of a pre-existing thrombus in the heart, which could be dislodged during the cardioversion procedure and cause a stroke.
EMANATE, a randomized, open-label clinical trial, will assess the effectiveness and safety of Eliquis compared with usual care (parenteral heparin and/or oral anticoagulation with a vitamin K antagonist) 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 will be performed after excluding 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 will be performed promptly without prior imaging. In all patients, Eliquis or usual care will be initiated prior to cardioversion and continued for up to 30 days post-cardioversion.
The EMANATE trial is anticipated to enroll 1,500 eligible patients from the United States, Canada, Europe and Asia. Patients will 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. Primary safety endpoints are major bleeding and clinically relevant non-major bleeding.
“We are pleased to enroll our first patient in the Phase 4 EMANATE study,” said Jack Lawrence, vice president, cardiovascular global clinical research and development lead, Eliquis, Bristol-Myers Squibb. “This Phase 4 trial will provide important data that will inform the use of Eliquis in patients with NVAF undergoing cardioversion.”
“Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with NVAF in a number of countries around the world, including in the United States, European Union and Japan,” said Steve Romano, senior vice president, head of Medicines Development Group for Global Innovative Pharmaceuticals, Pfizer Inc. “The initiation of the Phase 4 EMANATE study reinforces the long-term commitment of Bristol-Myers Squibb and Pfizer to understanding and improving health in patients with NVAF.”
Date: July 17, 2014