The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2008 |
End Date: | October 2013 |
LPL100601, 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)
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.
cardiovascular event (such as a heart attack or stroke) in people with coronary heart
disease.
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.
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.
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
We found this trial at
136
sites
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