A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects

Conditions: 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: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2007-005210-39-AT

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 11200

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 3682
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3638

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 <90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or hypotension requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
10. Refractory ventricular arrhythmias within the previous 24 hours.
11. Symptoms of New York Heart Association (NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours (see Attachment TABY.4 for NYHA CHF classifications).
Exclusion Criteria Related to Bleeding
12. Contraindicated for antiplatelet therapy.
13. Received fibrinolytic therapy as initial treatment for the index event.
14. Any history of bleeding diathesis.
15. Clinical findings associated, in the judgment of the investigator, with an unacceptably high risk of bleeding.
16. Any of the following:
• History of ischemic or hemorrhagic stroke
• Intracranial neoplasm, arteriovenous malformation, or aneurysm
• History of any TIA symptoms.
17. International Normalized Ratio (INR) known to be >1.5 if test is performed
18. Platelet count of <100,000/mm3
19. Anemia (hemoglobin [Hgb] <10 gm/dL)
21.History of spontaneous gastrointestinal or non-gastrointestinal internal bleeding requiring in-hospital treatment, unless the event has been definitively treated and, in the investigator’s opinion, has a low likelihood of recurrence.
22. Currently receiving hemodialysis or peritoneal dialysis.
Prior/Concomitant Therapy Exclusion Criteria
23. History of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).
24. Treated with ticlopidine within 5 days of randomization.
25. Receiving prasugrel treatment at the time of screening.
26. Receiving oral anticoagulants at the time of screening or are anticipated to require oral anticoagulants therapy during the course of the study.
27. 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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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