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

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.

Official Title

A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)

Conditions

• Atherosclerosis
• Cardiovascular Disease
• Coronary Heart Disease
• CV Risk

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further Details

Primary outcome measures

• 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]
  [ 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. ]
  [ Designated as safety issue: No ]

Secondary outcome measures

• The composite measure of major coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction or urgent coronary revascularization for myocardial ischemia
  [ 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. ]
  [ Designated as safety issue: No ]
• The composite measure of total coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction, hospitalization for unstable angina , or any coronary revascularization procedure
  [ 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. ]
  [ Designated as safety issue: No ]
• The time to individual components of MACE [cardiovascular death, myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal) ]
  [ 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. ]
  [ Designated as safety issue: No ]
• The time to the first occurrence of any component of the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke
  [ 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. ]
  [ Designated as safety issue: No ]
• All cause mortality
  [ 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. ]
  [ Designated as safety issue: No ]

Study arms and assigned interventions

1. Darapladib: Experimental
   • Single daily oral tablet
   • Drug: Darapladib
   • Lp-PLA2 inhibitor administered in addition to standard therapy
2. Placebo: Placebo Comparator
   • Single daily oral tablet
   • Drug: Placebo
   • Placebo administered in addition to standard therapy

Study Start

December 2008

Eligibility & Criteria

• Ages eligible for study: 18 years and older
• Genders eligible for study: Both
• Accepts healthy volunteers: No

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

Total Enrolment

15500

Contact Details

US GSK Clinical Trials Call Center
877-379-3718