Randomised, Parallel-group, Multicenter, Multinational Phase 2 Study Comparing Edoxaban, an Oral Factor Xa Inhibitor, with Warfarin for Stroke Prevention in Patients with Atrial Fibrillation

The primary objective of this study was to compare the safety of four fixed-dose regimens of edoxaban with warfarin in patients with non-valvular atrial fibrillation (AF). In this 12-week, parallel-group, multicentre, multinational study, 1,146 patients with AF and risk of stroke were randomised to edoxaban 30 mg qd, 30 mg bid, 60 mg qd, or 60 mg bid or warfarin dose-adjusted to a target international normalised ratio of 2.0–3.0.

Author(s): Jeffrey Weitz, Stuart Connolly, Isha Patel, Diego Salazar, Shashank Rohatagi, Mendel Jansen, Helen Kastrissios, Jingjing Jin, Satoshi Kunitada

Year: September 1, 2010