The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy TrialSTABILITY
Trial overview
Number of participants with first occurrence of any component of the composite of major adverse cardiovascular events (cardiovascular [CV] death, non-fatal myocardial infarction [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 4.25 years/average of 3.51 years)
Number of participants with first occurrence of any event in the composite of major coronary events (coronary heart disease [CHD] death, non-fatal MI, or urgent coronary revascularization [CR] for MI) during the time period for follow-up (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 4.25 years/average of 3.51 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 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 4.25 years/average of 3.51 years)
Number of participants with CV death 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 4.25 years/average of 3.51 years)
Number of participants with first occurrence of MI (fatal/non-fatal) 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 4.25 years/average of 3.51 years)
Number of participants with first occurrence of stroke (fatal/non-fatal) 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 4.25 years/average of 3.51 years)
Number of participants with first occurrence of any component of the composite of all-cause mortality, 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 4.25 years/average of 3.51 years)
Number of participants with all-cause mortality during the time period for vital status
Timeframe: From randomization until death or study completion (up to 4.49 years/average of 3.65 years)
Participation criteria
- Men or women at least 18 years old. Women must be post-menopausal or using a highly
- effective method for avoidance of pregnancy.
- Planned coronary revascularization (such as stent placement or heart bypass) or any other major
- surgical procedure.
- Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
- Chronic coronary heart disease
- At least one of the following:
- At least 60 years old
- Diabetes requiring treatment with medication
- Low HDL cholesterol ("good cholesterol")
- Currently smoke cigarettes or stopped smoking within the past 3 months
- 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 arterial disease.
- Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
- 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 expected to result in death within the next 2 years (other than heart disease)
- Severe asthma that is poorly controlled with medication
- Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
- Previous severe allergic response to food, drink, insect stings, etc.
- Drug or alcohol abuse within the past 6 months OR 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)
- Participation in a study of an investigational medication within the past 30 days
- Current participation in a study of an investigational device
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.