Treatment of Acute Coronary Syndrome in medically managed subjects enrolled within 10 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event. MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Product Name: Prasugrel
Product Code: LY640315
Pharmaceutical Form: Film-coated tablet
CAS Number: 389574-19-0
Current Sponsor code: CS-747 hydrochloride salt, LY640315
Other descriptive name: LY64031
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have had a UA/NSTEMI index event within 10 days (240 hours) prior to randomization (based on the disease diagnostic criteria in Section 4.1.1). 2. Have had a medical management strategy decision made with reasonable certainty; that is, neither PCI nor CABG is planned for treatment of the index event. • For subjects whose medical management decision and randomization occurs no later than 72 hours following onset of the index event, prior clopidogrel treatment is not a consideration for eligibility. • For subjects with a medical management decision who are randomized beyond 72 hours of onset of the index event, clopidogrel must be administered according to standard of care practice for ACS patients no later than 72 hours following the onset of the index event (as defined in Section 4.1.2). 3. Have had at least 1 of the following 4 high-risk features at the time of the UA/NSTEMI event: • Age =60 years • Prior MI evidenced by pre-existing Q waves, or demonstration of infarction on imaging studies, or prior documentation of elevated cardiac markers. • Diabetes Mellitus - defined by concomitant treatment with an oral hypoglycemic agent and/or insulin. • Coronary revascularization at least 30 days before the onset of the index ACS event (either PCI or CABG). 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: Cardiovascular Exclusion Criteria 5. Decision for medical management >72 hours after the onset of the index event without commercial clopidogrel treatment within 72 hours following the onset of the index event (Note: commercial clopidogrel treatment must continue daily thereafter until randomization). 6. Planned PCI or CABG as treatment for the index ACS event – either during the index hospitalization or thereafter. 7. PCI or CABG performed within the previous 30 days. 8. STEMI as the index event. 9. Cardiogenic shock within the previous 24 hours (defined as a systolic blood pressure 1.5 if test is performed 18. Platelet count of 2 weeks of daily treatment with NSAIDs or COX2 inhibitors during the study. General Exclusion Criteria 28. Unwilling to provide or not sufficiently mentally competent to provide written informed consent. 29. Study site personnel directly affiliated with the study or are immediate family of study site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 30. Employed by Eli Lilly and Company, Ube Industries Limited, Daiichi Sankyo Pharma Inc, the academic research organization (ARO), or the contract research organization (CRO) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical studies, but are not permitted to participate at a Lilly facility. Immediate famil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that prasugrel and aspirin is superior to clopidogrel and aspirin in the treatment of medically managed subjects enrolled within 10 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event. Superiority will be assessed by the reduction in risk of the composite endpoint of first occurrence of cardiovascular (CV) death, myocardial infarction (MI), or stroke throughout the study. The primary analysis will be conducted in a hierarchical manner, with evaluation of the primary endpoint performed first in medically managed UA/NSTEMI subjects ULN, AND either ischemic chest pain (or anginal equivalent) =20 minutes in duration, or ST-segment deviation =1 mm in one or more leads. If at the onset of the suspected event, the ischemic biomarker was still elevated as a result of the index event, then there must be demonstration of a falling biomarker level prior to the onset of the suspected event, and the subsequent peak of the ischemic biomarker must be 1.5 times the value prior to the onset of the suspected event. These criteria do not need to be met if the ischemic biomarker is not elevated prior to the onset of the suspected event. •CK-MB >3 times ULN on at least 1 sample within 24 hours following PCI (for subjects requiring emergent, urgent, or elective PCI at any time after randomization). •CK-MB >5 times ULN on at least 1 sample within 24 hours following CABG (for subjects requiring emergent, urgent, or elective CABG surgery at any time after randomization). •New Q waves =0.04 seconds or pathology distinct from that of the index event and thought to be new since randomization. In order to detect periprocedural MI in subjects undergoing PCI or CABG during the course of the study, it is recommended that 4 blood samples for CK-MB be drawn: 1 prior to the procedure and 3 within the first 24 hours after PCI/CABG. The second sample should be drawn | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Malta, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed