Daiichi Sankyo, a Japanese pharmaceutical company, has started enrolling patients into the ENSURE-AF multinational phase 3 study. 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 patients are expected to be enrolled in ENSURE-AF at approximately 250 clinical sites across North America and Europe.
"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. "This trial will provide us with insights on whether edoxaban can be a viable treatment option for non-valvular atrial fibrillation patients undergoing cardioversion."
Atrial fibrillation (AF) is a condition in which the heartbeat is rapid and irregular, and can potentially lead to a stroke. AF is a common condition, affecting approximately 2.3–3.4% of people in developed nations. Compared to those without AF, people with the arrhythmia have a 3–5 times higher risk of stroke. Strokes due to AF are nearly twice as likely to be fatal than strokes in patients without AF at 30 days and have poorer prognosis than non-AF related strokes, with a 50% increased risk of remaining disabled at three months.
"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."
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