Phase 3
N=15,828
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00799903 ↗Enrolled (actual)
15,828
Serious AEs
43.1%
Results posted
Aug 2017
Primary outcome: 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 Participants — p=0.199
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Darapladib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2013
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 |
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
Data sourced from ClinicalTrials.gov (NCT00799903). 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.