Evaluation of the Efficacy and Safety of Rivaroxaban (BAY59-7939) 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
- 发起方
- Bayer
- 入组人数
- 1,280
- 主要终点
- Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding
研究概览
简要总结
This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).
详细描述
Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years or older
- •Japanese male or female
- •Non- valvular atrial fibrillation documented by ECG
- •Patients with a risk of stroke and non-CNS systemic embolism
排除标准
- •Significant mitral stenosis
- •Patients in whom anticoagulants are contraindicated
研究组 & 干预措施
Rivaroxaban (Xarelto, BAY59-7939)
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Rivaroxaban (Xarelto, BAY59-7939)
Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
干预措施: Warfarin placebo (Drug)
Warfarin
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
干预措施: Warfarin (Drug)
Warfarin
Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
干预措施: Rivaroxaban placebo (Drug)
结局指标
主要结局
Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding
时间窗: Up to 2 days after the last dose
Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.
次要结局
- Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death(Up to 2 days after the last dose)
- Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism(Up to 2 days after the last dose)
- Event Rate of Non-CNS Systemic Embolism(Up to 2 days after the last dose)
- Event Rate of Myocardial Infarction(Up to 2 days after the last dose)
- Event Rate of Vascular Death(Up to 2 days after the last dose)
- Event Rate of Stroke With Serious Residual Disability(Up to 2 days after the last dose)
- Event Rate of All-cause Death(Up to 2 days after the last dose)
- Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death(Up to 2 days after the last dose)
- Event Rate of Stroke(Up to 2 days after the last dose)
- Event Rate of Adjudicated Major Bleeding(Up to 2 days after the last dose)
- Event Rate Adjudicated Non-major Clinically Relevant Bleeding(Up to 2 days after the last dose)