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

Recruiting in Palo Alto (17 mi)

+947 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Eligibility Criteria

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