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)

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Embolism; Atrial Fibrillation; Stroke

Treatments: Drug: placebo warfarin; Drug: warfarin tablets; Drug: Edoxaban tablets (low dose regimen-30mg); Drug: placebo edoxaban; Drug: Edoxaban tablets (high dose regimen-60mg)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00781391

DU176b-C-U301

Details and patient eligibility

About

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.

Enrollment: 21,105 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21,105 participants in 3 patient groups

Warfarin/placebo edoxaban

Active Comparator group

Description:

Warfarin tablets plus placebo Edoxaban tablets

Treatment:

Drug: placebo edoxaban

Drug: warfarin tablets

high dose edoxaban/placebo warfarin

Experimental group

Description:

Edoxaban tablets (60mg) plus warfarin placebo tablets

Treatment:

Drug: placebo warfarin

Drug: Edoxaban tablets (high dose regimen-60mg)

low dose edoxaban/placebo warfarin

Experimental group

Description:

Edoxaban tablets (30mg) plus warfarin placebo tablets

Treatment:

Drug: placebo warfarin

Drug: Edoxaban tablets (low dose regimen-30mg)