Last updated: 07/17/2024 17:39:11
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 TrialSOLID-TIMI 52
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: 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)
Secondary outcomes:
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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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 urgent coronary revascularization for myocardial ischemia during the time period for follow-up of cardiovascular events
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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)
Interventions:
Enrollment:
13026
Primary completion date:
2014-24-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Michelle L. O’Donoghue,MD, MPH; Eugene Braunwald, MD; Harvey D. White, MBChB, DSc; Dylan P. Steen, MD; Mary Ann Lukas, MD; Elizabeth Tarka, MD; P. Gabriel Steg, MD; Judith S. Hochman, MD; et al .Effect of Darapladib on Major Coronary Events After an Acute Coronary Syndrome: The SOLID-TIMI 52 Randomized Clinical Trial.JAMA.2014;312(10):1006-1015
Matthias Wuttke et al (200+ authors).A catalogue of molecular targets for kidney function from genetic 1 analyses of a million individuals.Nat Genet.2019;51:957–972
DOI: 10.1038/s41588-019-0407-x
Medical condition
acute coronary syndrome
Product
darapladib
Collaborators
The TIMI Study Group
Study date(s)
December 2009 to April 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Linden, New Jersey, United States, 07036
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000CVD
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Aurora, Illinois, United States, 60504
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2014-24-04
Actual study completion date
2014-24-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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