Stroke Clinical Trial
Official title:
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
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).
Status | Completed |
Enrollment | 14269 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Bayer |
United States, Venezuela, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) | The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. | Up to 4 years | No |
Primary | The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) | The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. | Up to 4 years | No |
Primary | The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety | The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment. | Up to 4 years | No |
Secondary | The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death | The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. | Up to 4 years | No |
Secondary | The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death | The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. | Up to 4 years | No |
Secondary | The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke | The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. | Up to 4 years | No |
Secondary | The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism | The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. | Up to 4 years | No |
Secondary | The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction | The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. | Up to 4 years | No |
Secondary | The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death | The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment. | Up to 4 years | No |
Secondary | All-cause Mortality | The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment. | Up to 4 years | No |
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