Cardiovascular Atlas
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ARISTOTLE

A large trial that compared the blood thinner apixaban with warfarin in people with atrial fibrillation who had at least one other risk factor for stroke. The authors conclude that apixaban was superior to warfarin in preventing stroke or a clot elsewhere in the body, caused less bleeding, and was linked with lower death from any cause.

Also called Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

  • Study
  • In this atlas

Overview

Design
Randomized, double-blind, parallel-group, active-controlled (warfarin) phase 3 trial. The registry gives allocation randomized, parallel model, double masking and primary purpose prevention. The abstract says the trial was designed to test noninferiority, with key secondary objectives of testing superiority for the primary outcome and for the rates of major bleeding and death from any cause.
Phase
Phase 3
Enrolled
  • 20,976 participants (enrolled count) (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), retrieved )
  • 18,201 patients (unknown count) (Apixaban versus warfarin in patients with atrial fibrillation, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT00412984
Started
(actual) (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), retrieved )
Primary completion
(actual) (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), retrieved )
Completion
(actual) (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), retrieved )
Results first posted
(Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), retrieved )
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, 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, Ukraine, United Kingdom, Hong Kong SAR China, Türkiye (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

ClinicalTrials.gov NCT00412984, a phase 3, randomized, double-blind, parallel-group, warfarin-controlled study sponsored by Bristol-Myers Squibb (industry), completed 2011-05-25. The main report is Granger et al., N Engl J Med 2011;365(11):981-92 (abstract read only). Enrollment differs by source: the registry gives 20976 and the abstract says 18,201 patients; the difference is not explained and not reconciled. The registry marks the results-first-posted date ESTIMATED, so no date type is recorded for it. No structured findings are recorded here; the numbers are on the claim.

Arms

  • Apixaban

    Intervention Apixaban

    Apixaban at 5 mg twice daily (abstract). The registry lists oral tablets of 5.0 mg or 2.5 mg twice daily.

  • Warfarin

    Intervention None named

    Warfarin adjusted to a target international normalized ratio of 2.0 to 3.0 (abstract). No separate entity is recorded for warfarin.

Findings

No findings are published for this study.

Record details

Record id
cardio:aristotle
Content hash
798d8059133166e59b2019cf7cb010deda25218be273e6fcdbcf5bd4ef6c2a7b