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 has been completed.
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: September 9, 2014
Last verified: September 2014

October 28, 2008
September 9, 2014
November 2008
April 2013   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00781391 on ClinicalTrials.gov Archive Site
  • To compare Edoxaban to warfarin with regard to the composite clinical outcome of stroke, SEE, and all-cause mortality, as well as each component separately. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • To compare Edoxaban to warfarin with regard to major bleeding as well as major plus clinically relevant non-major bleeding [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • To compare Edoxaban to warfarin with regard to the composite clinical outcome of stroke, SEE, and CV mortality, as well as each component separately [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare Edoxaban to warfarin with regard to MACE, defined for this Phase 3 study as a composite of non-fatal MI, non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding, as well as each component separately [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Atrial Fibrillation
  • Embolism
  • 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
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21105
May 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   United Kingdom,   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
 
NCT00781391
DU176b-C-U301
Yes
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
The TIMI Study Group
Not Provided
Daiichi Sankyo Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP