Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Bayer
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 th...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- Significant mitral stenosis
- Transient atrial fibrillation caused by a reversible disorder
- Active internal bleeding
- Severe disabling stroke
- History of intracranial bleeding
- Hemorrhagic disorders
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
14269 Patients enrolled
Trial Details
Trial ID
NCT00403767
Start Date
December 1 2006
End Date
September 1 2010
Last Update
April 29 2014
Active Locations (932)
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1
Birmingham, Alabama, United States
2
Dothan, Alabama, United States
3
Geneva, Alabama, United States
4
Mobile, Alabama, United States