Edoxaban Case Study

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Edoxaban was studied in the phase III Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial [Giugliano et al. 2013]. The ENGAGE AF-TIMI 48 trial was a three-group, randomized, double-blind, double-dummy multinational trial that compared two dosing regimens of edoxaban with warfarin in patients with AF [Ruff et al. 2010]. In brief, eligible patients were 21 years or older who had AF within 12 months prior to randomization, a CHADS2 score of 2 or above, and planned treatment with anticoagulation. Key exclusion criteria included AF due to a reversible cause, CrCl< 30 ml/min, increased risk of bleeding, recent acute coronary syndrome or stroke within
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