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Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

NCT00412984 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20976

Last updated 2018-07-03

Study results available
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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.

Conditions

Interventions

DRUG

warfarin

Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)

DRUG

apixaban

Oral tablets, 5.0 mg or 2.5 mg, twice daily

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2011-05-25
Completion
2011-05-25

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Singapore
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412984 on ClinicalTrials.gov