SB-480848 in Major Adverse Cardiovascular Events - Integrated Phase III Summary of Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28,855
- 主要终点
- The time to first occurrence of urgent coronary revascularization for myocardial ischemia
研究概览
简要总结
The overall objective of this integrated analysis is to evaluate the clinical safety and efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to placebo when added to standard of care in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to evaluate the effects of darapladib on the following endpoints: urgent coronary revascularization for myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major Adverse Cardiovascular Event (MACE), and heart failure requiring hospitalization. The first occurrent of MACE, Major and total coronary events as well as the individual components of MACE will also be evaluated descriptively.
详细描述
The objective of the integrated safety analysis is to characterize the safety profile of darapladib in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)).
The purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies, namely: urgent coronary revascularization for myocardial ischemia, stroke, subsequent MACE, and heart failure requiring hospitalization, For all other endpoints, the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •This is an integrated analysis therefore inclusion criteria are not applicable.
排除标准
- •This is an integrated analysis therefore exclusion criteria are not applicable.
研究组 & 干预措施
Group 1: subjects from LPL100601
randomized subjects in study LPL100601
干预措施: darapladib (Drug)
Group 1: subjects from LPL100601
randomized subjects in study LPL100601
干预措施: placebo (Drug)
Group 2: subjects from SB480848/033
randomized subjects in study SB480848/033
干预措施: darapladib (Drug)
Group 2: subjects from SB480848/033
randomized subjects in study SB480848/033
干预措施: placebo (Drug)
结局指标
主要结局
The time to first occurrence of urgent coronary revascularization for myocardial ischemia
时间窗: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.
time to the first occurrence of any urgent coronary revascularization for myocardial ischemia
The time to subsequent Major Adverse Cardiovascular Events (MACE)
时间窗: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.
time to subsequent composite of MACE (CV death, non-fatal MI or non-fatal stroke)
The time to first occurrence of stroke (fatal/non-fatal)
时间窗: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.
time to the first occurrence of stroke (fatal or non-fatal)
The time to first occurrence of heart failure requiring hospitalization
时间窗: visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study.
time to the first occurrence of heart failure requiring hospitalization
次要结局
未报告次要终点