CTRI/2010/091/000212已完成3 期
A Clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).(Short title: The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 [SOLID-TIMI 52] Trial)
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 11,500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11,500
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
入选标准
- •1.Signed written informed consent.
- •2.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.
- •3.Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry.
- •4.Clinically stable for 24 hours prior to study entry.
- •5.A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible.
- •6.At least one of the following:
- •7.At least 60 years old.
- •8.Myocardial infarction prior to the qualifying ACS event.
- •9.Diabetes mellitus requiring treatment with medication.
- •10.Diagnosed mild or moderate reduction in kidney function.
- •11.Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral artery disease.
排除标准
- •1.ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery.
- •2.No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI).
- •3.Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry.
- •4.Certain types of liver disease.
- •5.Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
- •6.Severe heart failure.
- •7.Blood pressure higher than normal despite lifestyle changes and treatment with medications.
- •8.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.
- •9.Severe asthma that is poorly controlled with medication.
- •10.Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry).
- •11.Previous severe allergic reaction to food, medications, drink, insect stings, etc.
- •12.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.
- •13.Certain medications that may interfere with the study medication (these will be identified by the study doctor).
- •14.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.
- •15.Previously took darapladib (SB-480848).
- •16.Participation in a study of an investigational medication within the past 30 days.
- •17.Current participation in a study of an investigational device.
- •18.Any other reason the investigator deems the subject should not participate in the study.
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