ClinicalTrials.Veeva

Menu

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

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status and phase

Completed
Phase 3

Conditions

Embolism
Atrial Fibrillation
Stroke

Treatments

Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo)
Drug: Warfarin
Drug: Rivaroxaban
Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00403767
CR012157
ROCKET AF (Other Identifier)
2006-004595-13 (EudraCT Number)
39039039AFL3001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

Full description

Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). Treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study). Patients assigned to rivaroxaban will receive rivaroxaban 20 mg orally (p.o.) once daily (OD) plus warfarin placebo p.o. OD titrated to a target sham international normalized ratio (INR) of 2.5. Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. OD. Patients assigned to warfarin will receive warfarin p.o. OD titrated to a target INR of 2.5 plus rivaroxaban placebo p.o. OD. The maximum expected length of treatment is up to 32 months but may be extended up to 4 years.

Enrollment

14,269 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
  • History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus

Exclusion criteria

  • Significant mitral stenosis
  • Transient atrial fibrillation caused by a reversible disorder
  • Active internal bleeding
  • Severe disabling stroke
  • History of intracranial bleeding
  • Hemorrhagic disorders

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

14,269 participants in 2 patient groups

Rivaroxaban
Experimental group
Treatment:
Drug: Rivaroxaban
Drug: Matching placebo for Rivaroxaban arm (Warfarin placebo)
Warfarin
Active Comparator group
Treatment:
Drug: Warfarin
Drug: Matching placebo for Warfarin arm (Rivaroxaban placebo)

Trial contacts and locations

959

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems