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: 14 Aug 2017

At a glance

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

    • 17 Jul 2017 According to a Daiichi Sankyo media release, the European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for edoxaban [LIXIANA] to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion (treatment to restore a normal heart rhythm). The label update is based on results from this trial.
    • 15 Jun 2017 Results published in the American Journal of Cardiology.
    • 13 Mar 2017 According to a Daiichi Sankyo media release, data will be presented as poster at the American College of Cardiology's (ACC) 66th Annual Scientific Session March 2017.
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