The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial STABILITY

Not Applicable

• Conditions: -I25; I25

• Registration Number: PER-169-08
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified