Phase 3
Completed N=15,828
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Source: ClinicalTrials.gov NCT00799903 ↗Enrolled (actual)
15,828
Serious AEs
43.1%
Results posted
Aug 2017
Primary outcomePrimary: Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events — 819; 769 Participants — p=0.199
◆ Published Evidence
Highly cited
124citations · ~25 / year
Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study.
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.
Linked Publications (5)
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Plasma proteins associated with cardiovascular death in patients with chronic coronary heart disease: A retrospective study.
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Body Mass Index and Association With Cardiovascular Outcomes in Patients With Stable Coronary Heart Disease - A STABILITY Substudy.
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Serum Neurofilament Light Chain in Patients With Atrial Fibrillation.
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Diabetes status modifies the long-term effect of lipoprotein-associated phospholipase A2 on major coronary events.
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White blood cell counts can predict 4-year cardiovascular disease risk in patients with stable coronary heart disease: a prospective cohort study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events |
819; 769 | 0.199 |
| SECONDARY Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events |
814; 737 | 0.045 sig |
| SECONDARY Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events |
1269; 1159 | 0.019 sig |
| SECONDARY Number of Participants With CV Death During the Time Period for Follow-up of CV Events |
373; 359 | 0.594 |
| SECONDARY Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events |
405; 361 | 0.108 |
| SECONDARY Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events |
152; 154 | 0.920 |
| SECONDARY Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events |
962; 926 | 0.397 |
| SECONDARY Number of Participants With All-cause Mortality During the Time Period for Vital Status |
577; 582 | 0.870 |
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
Data sourced from ClinicalTrials.gov (NCT00799903) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.