Daiichi Sankyo Company announced on March 6 that the first patient had enrolled in a Phase 3b study evaluating edoxaban (Savaysa) versus a vitamin K antagonist in patients with atrial fibrillation following PCI with stenting.

The FDA has approved edoxaban to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The oral medication, a factor Xa inhibitor, is also indicated to treat deep vein thrombosis and pulmonary embolism following five to 10 days of initial therapy with a parenteral anticoagulant.

In this trial, known as ENTRUST-AF PCI, the researchers plan on enrolling 1,500 patients from 200 sites in Europe, Korea, Taiwan and Ukraine. The study’s primary endpoint is the incidence of major or clinically relevant non-major ISTH-defined bleeding.

During the study, patients will be randomized to receive a 12-month regimen of edoxaban once daily with clopidogrel or another P2Y12 antagonist or a regimen of a vitamin K antagonist with clopidogrel or another P2Y12 antagonist. All patients will also receive aspirin.

The patients in the study will all have atrial fibrillation for at least 12 months following a successful PCI with stenting.

“The optimal antithrombotic strategy for atrial fibrillation patients undergoing PCI with coronary stent implantation is unknown at this time,” Pascal Vranckx, MD, clinical consultant in interventional cardiology and medical director of Cardiac Critical Care Services at the Hartcentrum Hasselt in Belgium, said in a news release. “The ENTRUST-AF PCI study will evaluate the role of edoxaban as part of a dual antithrombotic treatment strategy compared to a vitamin K antagonist based antithrombotic strategy as recommended by current guidelines.”