A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
- Conditions
- -I24I24
- Registration Number
- PER-150-09
- Lead Sponsor
- GlaxoSmithKline,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 55
• 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method