Bristol-Myers Squibb (BMS) and Pfizer have initiated patient enrolment in a Phase IV clinical trial called EMANATE evaluating the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation (NVAF) undergoing cardioversion.
At present, Eliquis is approved to reduce the risk of stroke and systemic embolism in NVAF patients.
Cardioversion is a commonly used, effective method of converting atrial fibrillation to a normal rhythm, allowing the heart to pump more effectively.
In the randomised, open-label EMANATE ('Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with NVAF') trial, safety and efficacy of Eliquis will be evaluated compared with usual care started in patients with NVAF expected to undergo cardioversion after short-term anticoagulation, in a clinical practice setting.
The company said that 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 patients presenting within 48 hours of the onset of NVAF, cardioversion will be performed promptly without prior imaging.
In the trial, Eliquis or usual care will be initiated in all patients, prior to cardioversion and continued for up to 30 days post-cardioversion.
Anticoagulation is usually administered for a minimum of three weeks prior to cardioversion and for four weeks afterward.
In some patients, early cardioversion can be carried out 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.
Bristol-Myers Squibb Cardiovascular Global Clinical Research vice president Jack Lawrence said: "This Phase IV trial will provide important data that will inform the use of Eliquis in patients with NVAF undergoing cardioversion."
Approximately 1,500 eligible patients from the US, Canada, Europe and Asia will be enrolled in the trial and they will be randomised 1:1 to Eliquis or usual care, to be administered for about 30 days following early cardioversion or 90 days post-randomisation if cardioversion is not performed within this timeframe.
The primary efficacy endpoints of the trial are the occurrence of acute stroke, systemic embolism and all-cause death, while primary safety endpoints are major bleeding and clinically relevant non-major bleeding.