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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Atherosclerosis

Treatments: Drug: Darapladib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799903

100601

Details and patient eligibility

About

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

Full 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 return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Enrollment: 15,828 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

15,828 participants in 2 patient groups, including a placebo group

Darapladib

Experimental group

Description:

Single daily oral tablet

Treatment:

Drug: Darapladib

Placebo

Placebo Comparator group

Description:

Single daily oral tablet

Treatment:

Drug: Placebo