Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation (ENSURE-AF)
The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for a maximum of 82 days. Study procedures will include physical examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood clotting tests, blood samples, urine samples and completion of Quality of Life questionnaires.
The study is expected to show that edoxaban will provide comparable incidence rates for efficacy to warfarin plus enoxaparin, the current standard treatment, and will be at least as safe as warfarin for the incidence rate for bleeding
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- incidence of composite CV endpoints [ Time Frame: 58 days ]Compare the incidences of the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI) and cardiovascular (CV) mortality between the edoxaban group and the enoxaparin/warfarin group from randomization to end of follow up (FU) 58 days post cardioversion.
- incidence of major and CRNM bleeding [ Time Frame: 61 days ]Compare the incidence of the composite endpoints of major and clinically-relevant non-major (CRNM) bleeding between the edoxaban group and the enoxaparin/warfarin group from randomization to end of treatment (58 days post cardioversion) + 3 days
- incidence of composite CV endpoints and major bleeding [ Time Frame: 58 days ]Compare the incidences of the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI), cardiovascular (CV) mortality and major bleedings between the edoxaban group and the enoxaparin/warfarin group from randomization to end of FU (58 days post cardioversion).
|Study Start Date:||March 2014|
|Study Completion Date:||February 2016|
|Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: edoxaban treatment
Factor Xa inhibitor anticoagulant, oral, edoxaban tablet, 60 or 30 mg QD,28-49 days dosing
Factor Xa inhibitor anticoagulant, oral, edoxaban tablet, 60 or 30 mg once-daily (QD), 28-49 days dosing
Active Comparator: enoxaparin / warfarin
Vitamin K antagonist, sq/oral, 100mg/kg or 1 or 2.5 mg tablet QD, 28-49 days
Vitamin K antagonist, sq, 100mg/kg, 28-49 daysDrug: Warfarin
Vitamin K antagonist, oral, 1 or 2.5 mg tablet QD, 28-49 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT02072434
Show 225 Study Locations
|Principal Investigator:||Andreas Goette, MD||Kardiologie und Internistische Intensivmedizin|