PER-150-09已完成未知
A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
GlaxoSmithKline,0 个研究点目标入组 55 人开始时间: 2010年2月19日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 至 99（—）
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.
研究者
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