LIXIANA® (EDOXABAN) CLINICAL TRIAL DESIGNS

Efficacy and safety demonstrated in 2 robust phase 3 clinical trials1-4

Engage AF-TIMI 48
Engage AF-TIMI 48

ENGAGE AF‐TIMI 48 is the largest (21,105 patients) and longest (median follow-up duration of 2.8 years) trial for stroke prevention in atrial fibrillation to date.1,3

  • A phase 3, randomized, double-blind, double dummy, event-driven trial designed to evaluate the efficacy of LIXIANA® (edoxaban) compared with well-managed warfarin for noninferiority1
  • The primary efficacy endpoint was reduction in risk of stroke or systemic embolic events, and the primary safety endpoint was reduction in risk of major bleeding events1
  • ENGAGE AF-TIMI 48 Trial enrolled a high percentage of eligible patients with nonvalvular atrial fibrillation who also had at least 1 comorbidity or other factors that increase bleeding risk1


To date, Hokusai‐VTE is the largest (8292 patients) single study of venous thromboembolism (VTE) that studied eligible patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE).2,4

  • A phase 3, randomized, double-blind, double-dummy, event-driven trial that evaluated the efficacy and safety of LIXIANA® (edoxaban) compared with well-managed warfarin for noninferiority across a broad range of patients with VTE2
  • The primary efficacy outcome was the incidence of adjudicated symptomatic recurrent VTE; the principal safety outcome was the incidence of adjudicated clinically relevant bleeding2
  • The Hokusai-VTE Trial studied a high percentage of eligible patients with VTE who also had at least 1 comorbidity or other risk factor2