A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate theEffect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients WhoHave Recently Experienced an Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18,000
- 试验地点
- 64
- 主要终点
- Time from randomization to first occurrence of one of the following clinical events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization
研究概览
简要总结
The primary objective of this study is to compare the effect of SAR236553 with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s). This study will be done in about 50 countries and will enroll about 18000 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Recently hospitalized for ACS For complete list of exclusion criteria, please contact sponsor.
排除标准
- •Age less than 40 years; ACS event occurring more than 16 weeks prior to randomization visit; LDL-C likely to be < 70 mg/dL (< 1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia For complete list of exclusion criteria, please contact sponsor.
结局指标
主要结局
Time from randomization to first occurrence of one of the following clinical events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization
时间窗: up to 64 months
次要结局
- Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality(up to 64 months)
- Change from baseline in blood lipids and lipoprotein levels(Up to 64 months)
- Number of patients with adverse events(Up to 64 months)