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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14,269
- 主要终点
- The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Significant mitral stenosis
- •Transient atrial fibrillation caused by a reversible disorder
- •Active internal bleeding
- •Severe disabling stroke
- •History of intracranial bleeding
- •Hemorrhagic disorders
研究组 & 干预措施
Rivaroxaban
干预措施: Rivaroxaban (Drug)
Rivaroxaban
干预措施: Matching placebo for Rivaroxaban arm (Warfarin placebo) (Drug)
Warfarin
干预措施: Warfarin (Drug)
Warfarin
干预措施: Matching placebo for Warfarin arm (Rivaroxaban placebo) (Drug)
结局指标
主要结局
The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
时间窗: Up to 4 years
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.
The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
时间窗: Up to 4 years
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.
The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
时间窗: Up to 4 years
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.
次要结局
- The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death(Up to 4 years)
- The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death(Up to 4 years)
- The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke(Up to 4 years)
- The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism(Up to 4 years)
- The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction(Up to 4 years)
- The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death(Up to 4 years)
- All-cause Mortality(Up to 4 years)