Okumura K, Akao M, Yoshida T, et al. - Among elderly Japanese patients (≥ 80 years of age), this phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven trial was performed to compare a once-daily 15-mg dose of edoxaban with placebo in this patient population with nonvalvular atrial fibrillation who were not considered to be suitable candidates for oral anticoagulant therapy at doses approved for stroke prevention. The composite of stroke or systemic embolism was the primary efficacy endpoint. Major bleeding as per the definition of the International Society on Thrombosis and Haemostasis was the primary safety endpoint. Findings demonstrated the superiority of a once-daily 15-mg dose of edoxaban over placebo in preventing stroke or systemic embolism. This treatment regimen did not cause a significantly higher incidence of major bleeding in comparison with placebo.