The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Condition: Atherosclerosis
MeSH terms: Heart Diseases; Atherosclerosis
Intervention: Darapladib; Placebo
Intervention description: Lp-PLA2 inhibitor administered in addition to standard therapy; Placebo administered in addition to standard therapy
Intervention MeSH terms: Darapladib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15828.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart disease; Lp-PLA2 inhibitor; cardiovascular disease; coronary heart disease; CV risk; Atherosclerosis

Summary:

      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.
    

Eligibility 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:

          -  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