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)

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

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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)