None listed
Conditions
Interventions
Group 1 Type of group
Darapladib 160 mg Single daily oral tablet
Group name:Group 2 Type of group
Placebo Single daily oral tablet
Sponsors
GlaxoSmithKline,
Eligibility
Age
19 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Signed written informed consent. • Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be post-menopausal or using a highly effective method for avoidance of pregnancy. • Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry. • Clinically stable for 24 hours prior to study entry. • A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible. • At least one of the following: • At least 60 years old. • Myocardial infarction prior to the qualifying ACS event. • Diabetes mellitus requiring treatment with medication. • 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 artery disease.
Exclusion criteria
Exclusion criteria: • ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery. • No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI). • Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry. • Certain types of 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 with a life expectancy of less than 2 years (other than heart disease) that may prevent the subject from completing the study. • Severe asthma that is poorly controlled with medication. • Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry). • Previous severe allergic reaction to food, medications, drink, insect stings, etc. • Drug or alcohol abuse within the past 6 months. 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). • If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded. • Previously took darapladib (SB-480848). • Participation in a study of an investigational medication within the past 30 days. • Current participation in a study of an investigational device. • Any other reason the investigator deems the subject should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (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 nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR 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 During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event Timepoints:From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) | — |
Secondary
| 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 or results in death (in 24 hours or results in death (in <24 hours). Measure:Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events Timepoints:From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years) ; Outcome name:Acute MI is defined as 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. CHD death is defined as the occurrence of a fatal MI, death caused by | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungaria, India, Israel, Italy, Japan, Korea South, Mexico, Netherlands, Norway, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed