# ARISTOTLE

Study · id `cardio:aristotle` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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

Browse, organ or system: Heart  
Browse, condition area: Stroke; Heart rhythm problems  

## In plain language

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.

## 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. 2011;365(11):981-92 (abstract read only; the journal is on the cited PubMed record). 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.

## Key facts

- 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: 20976 participants (enrolled count; Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), snapshot `cardio:ctgov-nct00412984-2026-10-14`, retrieved 2026-10-14); 18201 patients (unknown count; Apixaban versus warfarin in patients with atrial fibrillation, snapshot `cardio:pubmed-21870978-2026-10-14`, retrieved 2026-10-14)
- Started: 2006-12-31 (actual) (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), snapshot `cardio:ctgov-nct00412984-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2011-05-25 (actual) (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), snapshot `cardio:ctgov-nct00412984-2026-10-14`, retrieved 2026-10-14)
- Completion: 2011-05-25 (actual) (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), snapshot `cardio:ctgov-nct00412984-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2013-04-29 (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE), snapshot `cardio:ctgov-nct00412984-2026-10-14`, retrieved 2026-10-14)
- 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), snapshot `cardio:ctgov-nct00412984-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct00412984-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests apixaban against warfarin: Apixaban (`cardio:apixaban`)
- Lists atrial fibrillation as its first condition: Atrial fibrillation (AF) (`cardio:atrial-fibrillation`)

## Provenance

Content hash: 7a727398e135236b9fbaa75c4786950524538d4be126353dc1b4bbad5befe04f
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14