LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15,828
- 试验地点
- 1
- 主要终点
- Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
研究概览
简要总结
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.
详细描述
Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.
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
- •Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- •Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
- •Chronic coronary heart disease
- •At least one of the following:
- •At least 60 years old
- •Diabetes requiring treatment with medication
- •Low HDL cholesterol ("good cholesterol")
- •Currently smoke cigarettes or stopped smoking within the past 3 months
- •Diagnosed mild or moderate reduction in kidney function
- •Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.
排除标准
- •Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
- •Liver disease
- •Severe reduction in kidney function OR removal of a kidney OR kidney transplant
- •Severe heart failure
- •Blood pressure higher than normal despite lifestyle changes and treatment with medications
- •Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)
- •Severe asthma that is poorly controlled with medication
- •Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
- •Previous severe allergic response to food, drink, insect stings, etc.
- •Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
- •Certain medications that may interfere with the study medication (these will be identified by the study doctor)
- •Participation in a study of an investigational medication within the past 30 days
- •Current participation in a study of an investigational device
研究组 & 干预措施
Darapladib
Single daily oral tablet
干预措施: Darapladib (Drug)
Placebo
Single daily oral tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
时间窗: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \>24 hours or results in death (in \<24 hours).
次要结局
- Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))
- Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))
- Number of Participants With CV Death During the Time Period for Follow-up of CV Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))
- Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))
- Number of Participants With All-cause Mortality During the Time Period for Vital Status(From randomization until death or study completion (up to 4.49 years/average of 3.65 years))
- Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))
- Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years))