Cardiovascular Atlas
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ROCKET AF

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.

  • Study
  • In this atlas

Overview

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
  • 14,269 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), retrieved )
  • 14,264 patients (randomized count) (Rivaroxaban versus warfarin in nonvalvular atrial fibrillation, retrieved )
Sponsor
  • Bayer Collaborator on the registry record
Funder
Not recorded
Registry
  • NCT NCT00403767
Started
(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), retrieved )
Primary completion
(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), retrieved )
Completion
(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), retrieved )
Results first posted
(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), retrieved )
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), retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

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., N Engl J Med 2011;365(10):883-91 (abstract read only). 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.

Arms

  • Rivaroxaban

    Intervention Rivaroxaban

    Rivaroxaban at a daily dose of 20 mg (abstract). The registry lists one 20 mg tablet once daily, with a dose adaptation to 15 mg once daily for moderate renal impairment, and a matching warfarin placebo.

  • Warfarin

    Intervention None named

    Dose-adjusted warfarin (abstract), with a matching rivaroxaban placebo (registry). No separate entity is recorded for warfarin.

Findings

No findings are published for this study.

Record details

Record id
cardio:rocket-af
Content hash
38cac87a82c38b2b8b801d72205c7a03ba60ed77da5041018b8ee6f84ba7393a