None listed
Conditions
Interventions
Group 1 Type of group
160 mg tablets of enteric-coated darapladib (a daily oral dose) added to standard treatment in a population of patients suffering from chronic coronary heart disease.
Group name:Group 2 Type of group
Placebo tablets (a daily oral dose) added to the standard treatment in a population of patients suffering from chronic coronary heart disease.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours). Measure: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 Timepoints:From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR. Measure: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 Timepoints:From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years) ; Outcome name:CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Korea South, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactMilagros Cardenas
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed