placebo + warfarin

placebo + warfarin refers to the control treatment arm used in the ENGAGE AF-TIMI 48 Phase 3 clinical trial sponsored by Daiichi Sankyo. This regimen consists of active warfarin tablets, titrated to a target International Normalized Ratio (INR) of 2.0 to 3.0, administered alongside a placebo version of edoxaban to maintain the double-blind, double-dummy study design. The trial evaluated the efficacy and safety of edoxaban (a direct oral factor Xa inhibitor) compared to warfarin for the prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation. Warfarin, the active component of this regimen, is a small molecule vitamin K antagonist that inhibits the vitamin K epoxide reductase complex, thereby reducing the synthesis of active vitamin K-dependent clotting factors II, VII, IX, and X.

Other names

warfarin plus edoxaban placebowarfarin + placeboplacebo + warfarin-Daiichi Sankyo-atrial fibrillation