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

Condition(s) targeted: Coronary Arteriosclerosis; Acute Coronary Syndrome

Intervention: prasugrel (Drug); clopidogrel (Drug); placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559), Phone: 317-615-4559

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).

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

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

Primary outcome: 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

Secondary outcome:

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

To evaluate the safety and tolerability of switching subjects from clopidogrel to prasugrel

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

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

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559), Phone: 317-615-4559

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jacksonville, Florida 32209, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Baltimore, Maryland 21215, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Worcester, Massachusetts 01655, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ann Arbor, Michigan 48109, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cincinnati, Ohio 45219, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Columbus, Ohio 43210, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Oklahoma City, Oklahoma 73104, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rapid City, South Dakota 57701, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Houston, Texas 77024, United States; Recruiting
Eli Lilly

Lilly Clinical Trial Registry

Starting date: July 2006
Ending date: November 2008
Last updated: April 14, 2008