Effect of Prasugrel on Platelets After One Week in Patients Already Taking Clopidogrel After a Cardiac Event

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).

Intervention(s) in this Clinical Trial

• Drug: prasugrel 10 mg
  • 10 mg tablet taken orally
• Drug: clopidogrel
  • 75 mg tablet taken orally
• Drug: prasugrel placebo
  • oral, as blinding mechanism.
• Drug: prasugrel 60 mg
  • 60 mg (six 10-mg tablets) taken orally
• Drug: clopidogrel placebo
  • oral, as blinding mechanism

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Prasugrel 10/10 mg
  • Open label (lead-in) dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
• Experimental: Clopidogrel 75/75 mg
  • Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
• Experimental: Prasugrel 60/10 mg
  • Open label (lead-in) dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, assignment to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.

Primary Measures

• Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)
  • Time Frame: 1 week after first dose of randomized study drug
    Safety Issue?: No

Secondary Measures

• Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
  • Time Frame: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug
    Safety Issue?: No
• Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event
  • Time Frame: End of 14 day open label
    Safety Issue?: No
• Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
  • Time Frame: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug
    Safety Issue?: No
• Correlation Coefficent of Verify Now™ P2Y12 Assay Values to Maximum Platelet Aggregation (MPA) and Residual Platelet Aggregation (RPA) to 20 uM ADP at 1 Week
  • Time Frame: 1 week after randomized study drug
    Safety Issue?: No
• Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
  • Time Frame: End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug
    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 less 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 (percutaneous coronary intervention [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 kilograms (kg).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 74 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

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 February 09, 2012

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