Daiichi Sankyo Begins Phase 3 Study For Edoxaban

Daiichi Sankyo announced that it has initiated enrollment of patients into the multinational Phase III study ENSURE-AF evaluating the safety and efficacy of edoxaban against enoxaparin and warfarin.

The ENSURE-AF is a Prospective, Randomized, Open-Label, Blinded Endpont evaluation (PROBE) parallel group study involving patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm). The trial will evaluate edoxaban’s ability to prevent stroke, systemic embolic event, myocardial infarction, and cardiovascular mortality.

“This is a very exciting study, as this will be the largest planned clinical trial to evaluate a novel oral anticoagulant with the current standard of care in patients undergoing cardioversion. The novel oral anticoagulants offer the possibility of efficacy, safety, and convenience for the peri-cardioversion management of patients with atrial fibrillation,” said Gregory Lip, professor of cardiovascular medicine at the University of Birmingham in UK.

Atrial fibrillation (AF) is a serious condition in which the heartbeat is rapid and irregular. The condition can lead to a stroke, which is the second most common cause of death worldwide (6.2 million deaths per year). Atrial fibrillation is a common condition, affecting about 2.3 percent to 3.4 percent of people living in developed nations.

Edoxaban is an investigational oral, once daily direct factor Xa inhibitor. Factor Xa is critical in the coagulation system which leads to blood clotting.

“Due to the risk of thromboembolism, clinical guidelines recommend anticoagulation before and after cardioversion in patients with atrial fibrillation. This trial will provide us with insights on whether edoxaban can be a viable treatment option for non-valvular atrial fibrillation patients undergoing cardioversion,” said Andreas Goette, chief physician in the department of cardiology and intensive care medicine at St. Vincenz-Hospital Paderborn in Germany.

The company said over 2,200 patients will be enrolled in the trial at about 250 clinical sites across Europe and North America.