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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History