A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15,871
- 主要终点
- Incidence of Cardiovascular Mortality and Morbidity
研究概览
简要总结
This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo po, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=45 years of age;
- •recently hospitalized for ACS;
- •clinically stable;
- •receiving evidence-based medical and dietary management of dyslipidemia.
排除标准
- •uncontrolled diabetes;
- •clinically unstable;
- •severe anemia;
- •uncontrolled hypertension;
- •concomitant treatment with any other drug raising HDL-C (eg niacin, fibrates).
研究组 & 干预措施
Dalcetrapib (RO4607381)
干预措施: Dalcetrapib (RO4607381) (Drug)
Dalcetrapib (RO4607381)
干预措施: Evidence-based medical care for Acute Coronary Syndrome (Drug)
Placebo
干预措施: Evidence-based medical care for Acute Coronary Syndrome (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Cardiovascular Mortality and Morbidity
时间窗: From date of randomization to first event up to 48 months
Number of cardiovascular events per patient per year
次要结局
- Composite Endpoint:All Cause Mortality(Throughout Study, up to 53 Months)
- Change From Baseline for HDL Cholesterol(At 53 Months)
- Adverse Events, Lab Parameters, Vital Signs, ECG(Throughout Study, up to 53 Months)