Reduction of atherothrombotic events in patients with acute coronary syndromes (ACS) that is patients with ST-segment elevation MI [STEMI], non-ST-segment elevation MI [NSTEMI], or unstable angina [UA], who are to undergo percutaneous coronary intervention (PCI). MedDRA version: 7.0 Level: HLT Classification code 10011085
Conditions
Interventions
Product Name: Prasugrel
Product Code: CS-747
LY640315
Pharmaceutical Form: Film-coated tablet
CAS Number: 389574-19-0
Current Sponsor code: CS-747 hydrochloride salt, LY640315
Other descriptive name: LY640315
Concentration unit: mg milligram(s)
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the study only if they meet all of the following criteria: [1] Present with acute coronary syndrome based on the disease diagnostic criteria and are to undergo percutaneous coronary intervention (PCI). [2] Are of a legal age (and at least 18 years of age) and competent mental condition to provide written informed consent before entering the study. Informed consent must be signed by the study participant or authorized representative, according to local rules and regulations. [3] For women of child-bearing potential only (that is, women who are not surgically or chemically sterilized and who are between menarche and 1 year postmenopause), test negative for pregnancy between ACS presentation and enrollment (based on a urine or serum pregnancy test) and agree to use a reliable method of birth control during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they meet any of the following criteria: Cardiovascular Exclusion Criteria [4] Have cardiogenic shock [5] Have refractory ventricular arrhythmias. [6] Have NYHA Class IV congestive heart failure Bleeding Risk Exclusion Criteria [7] Have received fibrin-specific fibrinolytic therapy 1.5 at the time of evaluation. [13] Have a platelet count of 2 weeks of daily treatment with NSAID or COX2 inhibitors during the study. General Exclusion Criteria [21] Have previously completed or withdrawn from this study or any other study investigating CS-747. [22] Are women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding. [23] 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 (maximum of 15 months). [24] Have known severe hepatic dysfunction (i.e. cirrhosis or portal hypertension). [25] Have a condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence. [26] Have a history of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that CS-747 plus aspirin is superior to clopidogrel plus aspirin in the treatment of subjects with acute coronary syndrome who are to undergo percutaneous coronary intervention, as measured by a reduction in the composite endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke at a median follow-up of at least 12 months. CS-747 will be given as an oral loading dose of 60 mg, followed by an oral maintenance dose of 10 mg once daily (QD). Clopidogrel will be given as an oral loading dose of 300 mg, followed by an oral maintenance dose of 75 mg QD. The primary endpoint will be analyzed first in the subjects with unstable angina (UA) and non-ST-segment elevation myocardial infarction (NSTEMI), followed by analysis of the same endpoint in all ACS subjects (UA, NSTEMI and ST-segment elevation myocardial infarction [STEMI]).;Secondary Objective: To compare CS-747 with clopidogrel with respect to the risk of: · CV death, MI or UTVR at 30 and 90 days. · CV death, MI or stroke at 30 and 90 days. · CV death, MI, stroke or rehospitalization for cardiac ischemic events at a median of at least 12 months. · All-cause death, MI or stroke at a median of at least 12 months. These endpoints will be analyzed in both the UA/NSTEMI population and the entire ACS population The safety objectives for this study are to evaluate the: · Incidence of non-CABG-related TIMI major bleeding. · Incidence of life-threatening bleeding. · Incidence of non-CABG-related TIMI minor bleeding. · Overall safety and tolerability of CS-747 based on clinical findings, laboratory values and the occurrence of TEAEs.;Primary end point(s): The primary endpoint is the composite of CV death, nonfatal MI, or nonfatal stroke. Due to a potentially varying hazard ratio, the primary analysis will be the time from randomization to the onset of the first occurrence of the primary endpoint using the Gehan-Wilcoxon test | — |
Countries
Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Slovakia, Spain, Sweden
Outcome results
None listed