Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF) (ENSURE-AF)
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|ClinicalTrials.gov Identifier: NCT02072434|
Recruitment Status : Completed
First Posted : February 26, 2014
Results First Posted : March 13, 2019
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Edoxaban Drug: Warfarin Drug: Enoxaparin||Phase 3|
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 and urine samples.
The study is expected to show that edoxaban will provide comparable incidence rates to warfarin plus enoxaparin, the current standard treatment for both efficacy and bleeding.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 25, 2014|
|Actual Primary Completion Date :||February 3, 2016|
|Actual Study Completion Date :||February 3, 2016|
Edoxaban oral tablet, 60 mg-once daily (QD), reduced to 30 mg based on protocol-defined parameters, for up to 49 days
Edoxaban 30 mg tablets for oral administration
Active Comparator: Warfarin
Participants naïve to anticoagulation, taking anticoagulants other than a Vitamin K antagonist (VKA) or taking a VKA but with a prothrombin time (PT) international normalized ratio (INR) of less than 2.0 receive enoxaparin until they reach a PT INR of at least 2.0, before taking warfarin.
All participants in this arm receive warfarin oral tablet QD at their doctor's prescribed dose, for up to 49 days.
Warfarin tablet, 1.0 or 2.5 mg, for oral administration
Enoxaparin per label, at prescribed dose until PT INR at least 2.0
- Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up [ Time Frame: Randomization to end of follow-up (within 2 years) ]
- Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding [ Time Frame: During treatment period (within 2 years) ]
- Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding [ Time Frame: From randomization to the end of follow-up (within 2 years) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072434
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|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|