A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation

Trial Profile

A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2017

At a glance

  • Drugs Edoxaban (Primary) ; Enoxaparin sodium; Warfarin
  • Indications Stroke; Thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENSURE-AF
  • Sponsors Daiichi Sankyo Inc
  • Most Recent Events

    • 30 Aug 2017 Results of subanalysis comparing the primary efficacy and safety endpoints in relation to presence or absence of congestive heart failure, presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology.
    • 30 Aug 2017 Results of subanalysis (n=1183) assessing clinical predictors of transesophageal echocardiography detected left atrium thrombi (LAT), presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology.
    • 30 Aug 2017 Results of a post-hoc analysis assessing the relationship of renal function to outcome presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology.
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