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A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

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Trial Profile

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs Edoxaban (Primary) ; Warfarin
  • Indications Stroke; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENGAGE AF-TIMI 48; ENGAGE-AF
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 06 Mar 2023 Results of post-hoc analysis assessing the efficacy and safety of lower dose anticoagulants in the elderly subjects, presented at the 72nd Annual Scientific Session of the American College of Cardiology together with the World Heart Federation.
  • 04 Apr 2022 Results of a nested biomarker study in 8705 patients assessed high-sensitivity troponin T, N-terminal B-type natriuretic peptide, and growth differentiation factor-15 at baseline, as well as in serial samples after 12 months for subsequent events presented at the 71st Annual Scientific Session of the American College of Cardiology
  • 04 Apr 2022 Results of an analysis assessing the association of Neutrophil-Lymphocyte ratio with bleeding events and Cardiovascular death in patients with atrial fibrillation presented at the 71st Annual Scientific Session of the American College of Cardiology

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