CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,421 enrolled
Drug / intervention
Apixaban +1 moredrug
Likely dose
Apixaban 5 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.

Search/NCT00496769
NCT00496769Phase 3Completed
CompareCT.gov

Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial

Bristol-Myers Squibb·interventional·Posted Jul 4, 2007·Updated Jun 15, 2018

In Brief

A Phase 3 clinical trial evaluating Apixaban and Acetylsalicylic acid for Atrial Fibrillation. Completed, enrolled 6,421 participants across 503 sites in 36 countries.

Detailed Summary

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Malaysia, Mexico, Norway, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2007
Enrollment StartAug 31, 2007
Primary CompletionNov 30, 2010
Study CompletionMay 25, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.0 years ago

Interventions

Apixabandrug

Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks

Acetylsalicylic aciddrug

Tablets, oral, 81-324 mg, once daily, up to 156 weeks