Researchers have completed enrollment for the phase III ENGAGE AF-TIMI 48 clinical trial that will study of edoxaban, an anticoagulant and an oral factor Xa inhibitor used in the prevention of stroke and embolic event occurrence in atrial fibrillation (AF) patients.
The randomized, double-blind, multicenter trial will assess the efficacy and safety of edoxaban compared to warfarin in 21,107 patients at almost 1,400 clinical sites throughout the U.S., South America, Africa, Asia, Europe and Australia and New Zealand.
Patients will be randomized to receive either a 30 mg edoxaban once-daily dose, a once-daily 60 mg dose of edoxaban or warfarin. The primary endpoint will assess the incidence of major and relevant non-major bleeding events.
During the study, researchers will adjust the doses of edoxaban to treat patients with renal impairment and/or low body weight or those who are taking P-glycoprotein inhibitors. According to Daiichi Sankyo, patients who are randomized to warfarin are dosed once-daily to achieve an INR between 2 and 3.
"As new options to prevent stroke in AF patients become available, it will be important that these treatments eliminate the need for extensive monitoring and dietary modifications as well as deliver a balanced benefit to risk profile," said Elliott Antman, MD, the trial’s senior investigator and professor of medicine at Harvard Medical School, and director of the cardiac unit at Brigham and Women's Hospital, both in Boston.