A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15,526
- 主要终点
- The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
研究概览
简要总结
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.
详细描述
Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
- •Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital
排除标准
- •Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
- •Need for continued anticoagulant therapy
- •Significant renal impairment or known significant liver disease
研究组 & 干预措施
Rivaroxaban 2.5 mg bid
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
干预措施: Rivaroxaban 2.5 mg (Drug)
Rivaroxaban 2.5 mg bid
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
干预措施: Standard of care (Drug)
Rivaroxaban 5 mg bid
One 5 mg rivaroxaban tablet twice daily for up to 6 months
干预措施: Rivaroxaban 5 mg (Drug)
Rivaroxaban 5 mg bid
One 5 mg rivaroxaban tablet twice daily for up to 6 months
干预措施: Standard of care (Drug)
Placebo
One placebo tablet twice daily for up to 6 months
干预措施: Placebo (Drug)
Placebo
One placebo tablet twice daily for up to 6 months
干预措施: Standard of care (Drug)
结局指标
主要结局
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
时间窗: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
次要结局
- The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery(From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))
- The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization(From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))
- The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization(From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))
- The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke(From the time of randomization (Day 1) up to completion of the treatment phase (Month 6))