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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atrial Fibrillation, Stroke, Embolism

In brief

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).

Key facts

Study ID

NCT00403767

Run by

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

People needed

14269

Starts

2006-12-01

Expected to finish

2010-09-01

Last updated by the study team

2014-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Geneva, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Pell City, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fort Smith, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Bakersfield, California, United States
• Study site — Carmichael, California, United States
• Study site — Corona, California, United States
• Study site — Fair Oaks, California, United States
• Study site — Glendale, California, United States
• Study site — Healdsburg, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Gatos, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Modesto, California, United States
• Study site — Mountain View, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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