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


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current 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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00781391 on ClinicalTrials.gov Archive Site
Current 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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEGlobal Study to Assess the Safety and Effectiveness of DU-176b vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Official Title  ICMJEA 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)
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Stroke
  • Atrial Fibrillation
  • Embolism
Intervention  ICMJE
  • Drug: warfarin tablets
    Warfarin tablets plus DU-176b placebo tablets each taken once daily for 24 months
  • Drug: DU-176b tablets (high dose regimen)
    DU-176b tablets plus warfarin placebo tablets each taken once daily for 24 months
  • Drug: DU-176b tablets (low dose regimen)
    DU-176b tablets plus warfarin placebo tablets each taken once daily for 24 months
Study Arms / Comparison Groups
  • 1: Active Comparator
    Warfarin tablets plus placebo DU-176b tablets
    Intervention: Drug: warfarin tablets
  • 2: Experimental
    DU-176b tablets plus warfarin placebo tablets
    Intervention: Drug: DU-176b tablets (high dose regimen)
  • 3: Experimental
    DU-176b tablets plus warfarin placebo tablets
    Intervention: Drug: DU-176b tablets (low dose regimen)

Recruitment Information

Estimated Enrollment  ICMJE16500
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (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
GenderBoth
Ages21 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Shirali Patel919-998-1452shirali.patel@quintiles.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   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,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00781391
Responsible PartySenior Director, Clinical Development, Daiichi Sankyo
Study ID Numbers  ICMJEDU176b-C-U301
Study Sponsor  ICMJEDaiichi Sankyo Inc.
Collaborators  ICMJEThe TIMI Study Group
Investigators  ICMJE 
Information Provided ByDaiichi Sankyo Inc.