Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation (EngageAFTIMI48)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

The TIMI Study Group

Information provided by (Responsible Party):

Daiichi Sankyo Inc.

ClinicalTrials.gov Identifier:

NCT00781391

First received: October 28, 2008

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 28, 2008
Last Updated Date	August 31, 2012
Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2012)	The primary objective is to compare Edoxaban to warfarin with regard to the composite primary endpoint of stroke and systemic embolic events. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: October 28, 2008)	The primary objective is to compare DU-176b to warfarin with regard to the composite primary endpoint of stroke and systemic embolic events. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00781391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 31, 2012)	To compare Edoxaban to warfarin with regard to the composite clinical outcome of stroke, SEE, and all-cause mortality [ Time Frame: 24 Months ] [ Designated as safety issue: No ] To compare Edoxaban to warfarin with regard to major bleeding events [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 28, 2008)	To compare DU-176b to warfarin with regard to the composite clinical outcome of stroke, SEE, and all-cause mortality [ Time Frame: 24 Months ] [ Designated as safety issue: No ] To compare DU-176b to warfarin with regard to major bleeding events [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Official Title ^ICMJE	A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
Brief Summary	This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Stroke Atrial Fibrillation Embolism
Intervention ^ICMJE	Drug: warfarin tablets Warfarin tablets plus Edoxaban placebo tablets each taken once daily for 24 months Drug: Edoxaban tablets (high dose regimen) Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months Drug: Edoxaban tablets (low dose regimen) Edoxaban tablets plus warfarin placebo tablets each taken once daily for 24 months
Study Arm (s)	Active Comparator: 1 Warfarin tablets plus placebo Edoxaban tablets Intervention: Drug: warfarin tablets Experimental: 2 Edoxaban tablets plus warfarin placebo tablets Intervention: Drug: Edoxaban tablets (high dose regimen) Experimental: 3 Edoxaban tablets plus warfarin placebo tablets Intervention: Drug: Edoxaban tablets (low dose regimen)
Publications *	Salazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012 May 2;107(5):925-36. Epub 2012 Mar 8. Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	20500
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 21 years of age or older; male or female. Able to provide written informed consent. History of documented AF within the prior 12 months A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2 Exclusion Criteria: Transient atrial fibrillation secondary to other reversible disorders Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve Subjects with any contraindication for anticoagulant agents; Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders Females of childbearing potential including the following: Females with a history of tubal-ligation Females less than 2 years post-menopausal
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00781391
Other Study ID Numbers ^ICMJE	DU176b-C-U301
Has Data Monitoring Committee	Yes
Responsible Party	Daiichi Sankyo Inc.
Study Sponsor ^ICMJE	Daiichi Sankyo Inc.
Collaborators ^ICMJE	The TIMI Study Group
Investigators ^ICMJE	Not Provided
Information Provided By	Daiichi Sankyo Inc.
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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