PL100601 : The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY)

Phase 3

Completed

Conditions: Health Condition 1: null- Chronic Coronary Heart Disease

Registration Number: CTRI/2009/091/000443

Lead Sponsor: GlaxoSmithKline

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15500

Inclusion Criteria

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

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

Primary Outcome Measures

Name	Time	Method
Time to the first occurrence of any component of the composite of Major Adverse Cardiovascular Events [MACE: CV death (death due to a cardiovasacular cause), non-fatal myocardial infarction, non-fatal stroke]Timepoint: [Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years.]

Secondary Outcome Measures