A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome 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
- 13,026
- 试验地点
- 1
- 主要终点
- Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event
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 urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).
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, 6 months and every 6 months until the end of the study.
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
- •Signed written informed consent.
- •Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- •Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry.
- •Clinically stable for 24 hours prior to study entry.
- •A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible.
- •At least one of the following:
- •At least 60 years old.
- •Myocardial infarction prior to the qualifying ACS event.
- •Diabetes mellitus requiring treatment with medication.
- •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 artery disease.
排除标准
- •ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery.
- •No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI).
- •Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry.
- •Certain types of 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 with a life expectancy of less than 2 years (other than heart disease) that may prevent the subject from completing the study.
- •Severe asthma that is poorly controlled with medication.
- •Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry).
- •Previous severe allergic reaction to food, medications, drink, insect stings, etc.
- •Drug or alcohol abuse within the past 6 months. 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).
- •If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded.
- •Previously took darapladib (SB-480848).
- •Participation in a study of an investigational medication within the past 30 days.
- •Current participation in a study of an investigational device.
- •Any other reason the investigator deems the subject should not participate in the study.
研究组 & 干预措施
Placebo
Single daily oral tablet
干预措施: Standard Therapy (Other)
Darapladib 160 mg
Single daily oral tablet
干预措施: Darapladib 160 mg (Drug)
Darapladib 160 mg
Single daily oral tablet
干预措施: Standard Therapy (Other)
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 Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event
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 3.80 years)
Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. 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 nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.
次要结局
- Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- 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 the 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 3.80 years))
- Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, 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 3.80 years))
- Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))
- Number of Participants With All-cause Mortality During the Time Period for Vital Status(From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years))