Global Study to Assess the Safety and Effectiveness of DU-176b vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Collaborator:	The TIMI Study Group
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00781391

Purpose

This study is to demonstrate the safety and efficacy profile, in two different dose regimens of 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.

Condition	Intervention	Phase
Stroke Atrial Fibrillation Embolism	Drug: warfarin tablets Drug: DU-176b tablets (high dose regimen) Drug: DU-176b tablets (low dose regimen)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of DU-176b Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Blood Thinners

Drug Information available for: Warfarin Warfarin sodium

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20500
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Warfarin tablets plus placebo DU-176b tablets	Drug: warfarin tablets Warfarin tablets plus DU-176b placebo tablets each taken once daily for 24 months
Experimental: 2 DU-176b tablets plus warfarin placebo tablets	Drug: DU-176b tablets (high dose regimen) DU-176b tablets plus warfarin placebo tablets each taken once daily for 24 months
Experimental: 3 DU-176b tablets plus warfarin placebo tablets	Drug: DU-176b tablets (low dose regimen) DU-176b tablets plus warfarin placebo tablets each taken once daily for 24 months

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781391

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Sponsors and Collaborators

Daiichi Sankyo Inc.

The TIMI Study Group

More Information

No publications provided by Daiichi Sankyo Inc.

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

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.

Responsible Party:	Senior Director, Clinical Development, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00781391 History of Changes
Other Study ID Numbers:	DU176b-C-U301
Study First Received:	October 28, 2008
Last Updated:	March 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Systemic embolic events

Additional relevant MeSH terms:

Atrial Fibrillation
Embolism
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012