Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillatio

Phase 3

Recruiting

• Conditions: Stroke and Systemic Embolism; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12609000026224
• Lead Sponsor: Bristol-Myers Squibb Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

Males and females = 18 yrs with Atrial Fibrillation and one or more of the following risk factors for stroke:
- Age = 75, previous stroke
- Transient Ischemic Attack (TIA) or Systemic Embolism
- Symptomatic congestive heart failure or left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) = 40%
- Diabetes mellitus or hypertension requiring pharmacological treatment

Exclusion Criteria

- Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)

- Clinically significant (moderate or severe) mitral stenosis

- Increased bleeding risk that is believed to be a contraindication to oral anticoagulation (e.g. previous intracranial hemorrhage)

- Conditions other than atrial fibrillation that require chronic anticoagulation (e.g.
prosthetic mechanical heart valve)

- Persistent, uncontrolled hypertension (systolic Blood Pressure (BP) > 180 mm Hg, or diastolic BP
> 100 mm Hg)

- Planned major surgery

- Planned atrial fibrillation or flutter ablation procedure

- Required treatment with aspirin > 165 mg/day

- Recent ischemic stroke (within 7 days)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if apixaban is noninferior to warfarin (International Normalised Ratio target range 2.0 - 3.0) in the combined endpoint of stroke (ischemic or emorrhagic) and systemic embolism, in subjects with AF and at least one additional risk factor for stroke[At day 4, Week 1, Day 10, Week 2 and Week3, and every month until the latter of 30 days after treatment discontinuation<br>or the attainment of 448 primary study events.]