At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20,976 enrolled
Drug / intervention
warfarin +1 moredrug
Likely dose
warfarin 2.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating warfarin and apixaban for Atrial Fibrillation and Atrial Flutter. Completed, enrolled 20,976 participants across 1,111 sites in 41 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Flutter
CountriesArgentina, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2006
Enrollment StartDec 2006
Primary CompletionMay 2011
TodayJul 2026
First PostedDec 19, 2006
Enrollment StartDec 31, 2006
Primary CompletionMay 25, 2011
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 19.5 years ago
Interventions
warfarindrug
Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
apixabandrug
Oral tablets, 5.0 mg or 2.5 mg, twice daily