# ROCKET AF

Study · id `cardio:rocket-af` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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

## In plain language

A large trial that compared the blood thinner rivaroxaban with warfarin in people with non-valvular atrial fibrillation at increased risk of stroke. Rivaroxaban was shown to be no worse than warfarin at preventing stroke or a clot elsewhere in the body. It was not shown to be better in the analysis of everyone randomized, and the overall rate of major bleeding was similar.

## Technical summary

ClinicalTrials.gov NCT00403767, a phase 3, randomized, double-blind, parallel-group, non-inferiority study sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., with Bayer as collaborator, completed 2010-09. The main report is Patel et al. 2011;365(10):883-91 (abstract read only; the journal is on the cited PubMed record). The registry start date (2006-12) carries no actual-or-estimated type. Enrollment differs by source: the registry gives 14269 and the abstract says 14,264 patients were randomly assigned; 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, non-inferiority trial (registry: allocation randomized, parallel model, masking quadruple, primary purpose prevention). The abstract says the primary analysis was per-protocol and as-treated.
- Phase: Phase 3
- Enrolled: 14269 participants (enrolled count; An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF), snapshot `cardio:ctgov-nct00403767-2026-10-14`, retrieved 2026-10-14); 14264 patients (randomized count; Rivaroxaban versus warfarin in nonvalvular atrial fibrillation, snapshot `cardio:pubmed-21830957-2026-10-14`, retrieved 2026-10-14)
- Started: 2006-12 (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF), snapshot `cardio:ctgov-nct00403767-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2010-09 (actual) (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF), snapshot `cardio:ctgov-nct00403767-2026-10-14`, retrieved 2026-10-14)
- Completion: 2010-09 (actual) (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF), snapshot `cardio:ctgov-nct00403767-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2012-07-17 (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF), snapshot `cardio:ctgov-nct00403767-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; Chile; China; Colombia; Czechia; Denmark; Finland; France; Germany; Greece; Hungary; India; Israel; Lithuania; Malaysia; Mexico; Netherlands; New Zealand; Norway; Peru; Philippines; Poland; Romania; Russia; Singapore; South Africa; South Korea; Spain; Sweden; Switzerland; Taiwan; Thailand; Ukraine; United Kingdom; Venezuela; Hong Kong SAR China; Türkiye (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation (ROCKET AF), snapshot `cardio:ctgov-nct00403767-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct00403767-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests rivaroxaban against warfarin: Rivaroxaban (`cardio:rivaroxaban`)
- Lists atrial fibrillation as its first condition: Atrial fibrillation (AF) (`cardio:atrial-fibrillation`)
- Collaborator on the registry record: Bayer (`cardio:bayer`)

## Provenance

Content hash: 2c0f3237a56f94fdec0131a8848c184c5f06d04c9ad89e18e862f4fbd65edd7b
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14