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)

Study ID
STU 022011-020

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital—St. Paul

Contact
Colleen Debes
214-648-3112
colleen.debes@utsouthwestern.edu

Principal Investigator
James De Lemos

Summary

There will be about 20,500 subjects with AF enrolled in this research study at about 1,400 medical centers worldwide. Subjects will have an equal chance (1:1:1 ratio) of being assigned to each group:

* Warfarin

* DU-176b 30 mg once a day

* DU-176b 60 mg once a day

Subjects who have a body weight of ≤132lb (≤60 kg), have reduced kidney function, or take one or more of the following medications (verapamil, quinidine) will automatically receive a one-half reduced dose of DU-176b:

* DU-176b 15 mg once a day if you were assigned to 30 mg once a day

* DU-176b 30 mg once a day if you were assigned to 60 mg once a day
The patients will receive 2 sets of study drug. The first set is either DU-176b or matching placebo. The second set is either warfarin or matching placebo

Participant Eligibility

Inclusion Criteria:
1. Male or female subjects with age ≥ 21 years;
2. Able to provide written informed consent;
3. History of AF documented by any electrical tracing (routine 12-lead electrocardiogram [ECG], Holter monitor [continuous ECG recording] rhythm strip, intracardiac electrogram, or pacemaker [PM] or implantable cardiac defibrillator [ICD] interrogation) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study;
· Subjects with AF includes subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous VKA (including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
4. Subjects must have a CHADS2 index score ≥ 2. The CHADS2 scoring is performed by assigning 1 point each for a history of congestive heart failure, hypertension, age 75 years, or diabetes mellitus; and by assigning 2 points for history of stroke or TIA.