Official Title: “A Pharmacodynamic Comparison of Prasugrel (LY640315) Versus Clopidogrel in Subjects With Acute Coronary Syndrome Who Are Receiving Clopidogrel”

This study will compare the effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose on platelet activity, approximately 1 week after the first dose of study drug, in subjects who have been taking clopidogrel 75 mg daily following a percutaneous coronary intervention (PCI) with placement of a stent, performed to treat acute coronary syndrome (ACS).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacodynamics Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: prasugrel
  • A: 60 mg loading dose day 1 then 10 mg maintenance dose, oral, daily, 14 days B: 10 mg, oral, daily 14 days
• Drug: clopidogrel
  • 75 mg, oral, daily, 14 days
• Other: placebo
  • oral, as blinding mechanism A: as day 1 maintenance dose B: as loading dose C: as loading dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Each arm has a 10-14 day run in therapy of maintenance dose 75 mg clopidogrel
• Experimental: B
  • Each arm has a 10-14 day run in therapy of maintenance dose 75 mg clopidogrel
• Experimental: C
  • Each arm has a 10-14 day run in therapy of maintenance dose 75 mg clopidogrel

Primary Measures

• To compare the pharmacodynamic effect of a prasugrel 10-mg maintenance dose with a clopidogrel 75-mg maintenance dose, as assessed by difference in mean MPA to 20 micromolar ADP approximately
  • Time Frame: 1 week
    Safety Issue?: No

Secondary Measures

• To assess the pharmacodynamic effects (using MPA to 5 and 20 micromolar ADP) of a prasugrel 10-mg maintenance dose or prasugrel 60-mg loading dose/10-mg maintenance dose compared with a clopidogrel 75-mg maintenance dose
  • Time Frame: baseline, 2 hours, 24 hours, 1 week, 2 weeks
    Safety Issue?: No
• To evaluate the safety and tolerability of switching subjects from clopidogrel to prasugrel
  • Time Frame: every cycle
    Safety Issue?: Yes
• To evaluate variability in MPA to 20 micromolar ADP while taking clopidogrel in subjects who were taking clopidogrel at the time of the qualifying ACS event compared with subjects who were not taking clopidogrel at the time of the qualifying ACS event
  • Time Frame: over entire study
    Safety Issue?: No
• Pharmacodynamic effects on residual aggregation measured 6 minutes after the addition of 5 and 20 micromolar ADP of a prasugrel 10-mg maintenance dose or prasugrel 60-mg loading dose/10-mg maintenance dose to clopidrogel 75 mg maintenance dose
  • Time Frame: baseline, 2 hours, 24 hours, 1 week, 2 weeks
    Safety Issue?: No
• To compare the Accumetrics Verify NowTM P2Y12 device with LTA for monitoring platelet aggregation when subjects are switched from maintenance-dose clopidogrel to maintenance-dose prasugrel
  • Time Frame: every cycle
    Safety Issue?: Yes

Inclusion Criteria:

• Present with a recent history of an ACS event based on the disease diagnostic criteria between 30 and 330 days prior to enrollment, and who state that they are supposed to be taking daily aspirin and maintenance dose 75-mg clopidogrel
• Are of a legal age (and at least 18 years of age but no more than 75 years of age) and competent mental condition to provide written informed consent before entering the study

Exclusion Criteria:

• Left main coronary artery stent or left anterior descending (LAD) bifurcation stent
• Have any form of coronary revascularization (PCI or coronary artery bypass grafting
• [CABG]) planned to occur during the study (from signing consent through the final visit)
• Have undergone CABG or PCI within 30 days of entry into the study
• Receiving or will receive oral anticoagulation or other antiplatelet therapy (other than aspirin and clopidogrel) that cannot be safely discontinued for the duration of the study
• Receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) that cannot be discontinued or are anticipated to require daily treatment with NSAIDs during the study.
• Have any of the following:
• history of ischemic or hemorrhagic stroke intracranial neoplasm, arteriovenous malformation, or aneurysm history of transient ischemic attack (TIA) have a body weight less than 60 kg

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 am - 5 pm Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00356135

Study ID Number: 10631

ClinicalTrials.gov Identifier: NCT00356135

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry