Daiichi Sankyo initiates phase 3 ENSURE-AF study, investigating once-daily edoxaban in patients with atrial fibrillation undergoing cardioversion

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has started enrolling patients into the ENSURE-AF multinational phase 3 study, which will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm).^1,2 More than 2,200 patients are expected to be enrolled in ENSURE-AF at approximately 250 clinical sites across North America and Europe.¹

“Due to the risk of thromboembolism, clinical guidelines recommend anticoagulation before and after cardioversion in patients with atrial fibrillation,” said Andreas Goette, MD, Chief Physician, St. Vincenz-Hospital Paderborn, Germany, Department of Cardiology and Intensive Care Medicine and member of the European Heart Rhythm Association’s International Affairs Committee with responsibility for Japan.^3,4 “This trial will provide us with insights on whether edoxaban can be a viable treatment option for non-valvular atrial fibrillation patients undergoing cardioversion.”¹

“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” said Gregory YH Lip, Professor of Cardiovascular Medicine, University of Birmingham, UK. “The novel oral anticoagulants offer the possibility of efficacy, safety and convenience for the peri-cardioversion management of patients with atrial fibrillation.”

About ENSURE-AF

ENSURE-AF is a Prospective, Randomized, Open-Label, Blinded Endpont evaluation (PROBE), parallel group study, evaluating the efficacy and safety of once-daily edoxaban for the prevention of stroke, systemic embolic event, myocardial infarction and cardiovascular mortality versus enoxaparin/warfarin in patients with NVAF undergoing electrical cardioversion. More than 2,200 NVAF patients undergoing electrical cardioversion are expected to be enrolled at approximately 250 clinical sites across North America and Europe. Patients will be randomized to receive edoxaban 60 mg (or a patient specific dose of edoxaban 30 mg for patients with renal impairment or low body weight or p-glycoprotein inhibitor use) or enoxaparin/warfarin for 28-49 days.¹

For more information please visit: http://clinicaltrials.gov/show/NCT02072434.

References

1. Goette, A. Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation (ENSURE IN AF). In: Clini-calTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-2014. Available from http://clinicaltrials.gov/show/NCT02072434.
2. National Heart, Lung, and Blood Institute. What is Cardioversion. 2012. Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/crv/. [Last accessed: March 2014].
3. American College of Cardiology Foundation and American Heart Association. ACCF/AHA pocket guideline: management of patients with atrial fibrillation. 2011. Available at: http://www.cardiosource.org/~/media/Files/Science%20and%20Quality/Guidelines