A Study of Acute Coronary Syndrome Patients
- Registration Number
- CTRI/2010/091/000348
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
Present with acute coronary syndrome (ACS) consisting of unstable angina (UA), Non ST-elevated myocardial infarction (NSTEMI)or ST-elevated myocardial infarction (STEMI) and are to undergo percutaneous coronary intervention (PCI).
-Provide written informed consent (ICD) by participant or authorized representative
-Weigh at least 60 kilograms at the time of screening.
-For women of child-bearing potential (that is, women who are not surgically or chemically sterilized and who are between menarche and 1 year postmenopause), test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test and agree to use a reliable method of birth control during the study.
-Sign ICD for mandatory genetic testing.
Cardiovascular Exclusion Criteria
-Have cardiogenic shock at the time of randomization (systolic blood pressure >90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion.
-Have refractory ventricular arrhythmias
-Have New York Heart Association (NYHA) Class IV congestive heart failure
-Have systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 100 mm Hg.
-Have received fibrin-specific fibrinolytic therapy <24 hours prior to randomization.
-Have received nonfibrin-specific fibrinolytic therapy <48 hours prior to randomization.
-Have active internal bleeding or history of bleeding diathesis.
-Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
-Prior history of ischemic or hemorrhagic stroke.
-Intracranial neoplasm, arteriovenous malformation, or aneurysm.
-Prior history of transient ischemic attack (TIA).
-Have an International Normalized Ratio (INR) known to be >1.5 at the time of evaluation.
-Have a platelet count of <100,000/mm3 at the time of screening.
-Have anemia (hemoglobin [Hgb] <10 gm/dL) at the time of screening.
-Prior/Concomitant Therapy Exclusion Criteria
-Have received one or more doses of a thienopyridine (ticlopidine or clopidogrel) £10 days prior to PCI.
-Are receiving GPIIb/IIIa during their index admission.
-Are receiving or will receive oral anticoagulation or other antiplatelet therapy, other than aspirin (ASA), that cannot be safely discontinued for the duration of the study.
-Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require >2 weeks of daily treatment with NSAID or COX2 inhibitors during the study.
General Exclusion Criteria
-Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
-Have previously completed or withdrawn from this study or any other study investigating prasugrel.
-Are women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
-Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival over the expected treatment period.
-Have known severe hepatic dysfunction (that is, with cirrhosis or portal hypertension).
-Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).
-May be unable to cooperate with protocol requirements and follow-up procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference in ADP - induced P2Y12 receptor- mediated platelet aggregation (PRU)Timepoint: 6 hours after loading dose
- Secondary Outcome Measures
Name Time Method Mean change from baseline to 72 hours for laboratory measurements that are statistically different between treatment groupsTimepoint: Baseline to 72 hours;Number of treatment emergent adverse eventsTimepoint: 2 hours, 6 hours, 24 hours and 72 hours;P2Y12 Reaction Units (PRU)Timepoint: Baseline and 2 hours, 6 hours, 24 hours, and 72 hours after loading dose;Percentage of Inhibition of Platelet AggregationTimepoint: Baseline and 2 hours, 6 hours, 24 hours, and 72 hours after loading dose;Proportion of poor respondersTimepoint: Baseline and 2 hours, 6 hours, 24 hours, and 72 hours after loading dose