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Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF) (ENSURE-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02072434
Recruitment Status : Completed
First Posted : February 26, 2014
Results First Posted : March 13, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Edoxaban Drug: Warfarin Drug: Enoxaparin Phase 3

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 25, 2014
Actual Primary Completion Date : February 3, 2016
Actual Study Completion Date : February 3, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Edoxaban
Edoxaban oral tablet, 60 mg-once daily (QD), reduced to 30 mg based on protocol-defined parameters, for up to 49 days
 Drug: Edoxaban
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.

 Drug: Warfarin
Warfarin tablet, 1.0 or 2.5 mg, for oral administration

Drug: Enoxaparin
Enoxaparin per label, at prescribed dose until PT INR at least 2.0


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding [ Time Frame: During treatment period (within 2 years) ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has signed informed consent
  • Is older than minimum legal adult age (country specific)
  • Has had ongoing AF lasting at least 48 hrs but <= 12 months (with or without valvular heart disease)
  • Has treatment plan that includes for electrical cardioversion
  • Has NVAF or other specific valvular heart diseases (eg, mitral valve prolapse, mitral valve regurgitation, and aortic valve disease)

Exclusion Criteria:

  • Has AF that is transient or reversible
  • Has contraindicated condition, ie, conditions considered to be formal indication for conventional anticoagulation
  • Has a history of left atrial appendage (LAA) closure
  • Has a known thrombus in LAA, the left atrial, left ventricle or aorta - or an intracardial mass
  • Has had myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or percutaneous coronary intervention (PCI) within the past 30 days
  • Has any contraindication to anticoagulant agents
  • Has had protocol-defined signs of bleeding or conditions associated with high risk of bleeding that would preclude participation
  • Is receiving, or plans to receive during the study period, dual antiplatelet therapy (DAPT) or invasive procedures (other than routine endoscopy) in which bleeding would be anticipated
  • Has received prohibited concomitant medication or therapy
  • Has had protocol-defined signs of bleeding or high
  • Has inadequate liver, kidney, and blood test results
  • Received any investigational drug or device within the past 30 days or plans to during the study period
  • Has reproductive potential and does not agree to take proper contraceptive measures
  • Has active cancer requiring chemotherapy/radiation/major surgery within the next 3 months
  • Has significant active concurrent medical illness or infection or life expectancy less than 6 months
  • In the opinion of the investigator, is unlikely to comply with the protocol or complete the study, has had drug or alcohol dependence within the past year, or has any other condition that might place the participant at increased risk of harm
  • Is a participant in the United States after January 2015 with creatinine clearance (CrCL) greater than 95 mL/minute
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02072434    
Other Study ID Numbers: DU176b-F-E308
2013-003148-21 ( EudraCT Number )
First Posted: February 26, 2014    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
Nonvalvular atrial fibrillation (NVAF)
anti-coagulant
warfarin
edoxaban
electrical cardioversion
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Enoxaparin
Warfarin
Edoxaban
Anticoagulants
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors