Status:
COMPLETED
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
The TIMI Study Group
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 retur...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2014
Estimated Enrollment :
13026 Patients enrolled
Trial Details
Trial ID
NCT01000727
Start Date
December 1 2009
End Date
April 24 2014
Last Update
August 10 2017
Active Locations (914)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35243
2
GSK Investigational Site
Birmingham, Alabama, United States, 35294
3
GSK Investigational Site
Huntsville, Alabama, United States, 35801
4
GSK Investigational Site
Mobile, Alabama, United States, 36604