Full Content is available to subscribers and ACC Members Subscribe/Learn More > Original Investigation | August 2014 Transition of Patients From Blinded Study Drug to Open-Label Anticoagulation
Clinical Trials Thursday, August 7th, 2014J Am Coll Cardiol.: 6, August 2014
Background At the end of 2 previous trials, an excess of stroke and bleeding was observed in patients with AF randomized to a new oral anticoagulant (NOAC) who transitioned to a vitamin K antagonist (VKA).
Objectives The ENGAGE AF–TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation—Thrombolysis in Myocardial Infarction 48) trial compared once-daily edoxaban to warfarin for stroke prevention in patients with AF. An end-of-trial transition plan was developed to minimize the risks of stroke due to inadequate anticoagulation and bleeding from excessive anticoagulation during this critical period. Read More