NCT00412984

Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00412984

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

Summary

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Eligibility

Inclusion Criteria:

* Males and females ≥ 18 yrs with atrial fibrillation (AF) and one or more of the following risk factors for stroke:
* Age ≥ 75, previous stroke
* transient ischemic attack (TIA) or Systemic Embolism (SE)
* Symptomatic congestive heart failure or left ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40%
* Diabetes mellitus or hypertension requiring pharmacological treatment

Disease(s) and\or Condition(s)

Atrial Fibrillation

Atrial Flutter

Primary Purpose

PREVENTION

Intervention/Treatment

- Type: DRUG
- Name: warfarin
- Description: Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
- Arm Group Labels: 1
- Type: DRUG
- Name: apixaban
- Description: Oral tablets, 5.0 mg or 2.5 mg, twice daily
- Arm Group Labels: 2

Sponsor

Bristol-Myers Squibb