Clinical trial NCT00356135: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Arteriosclerosis
Acute Coronary Syndrome
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2006-07-25
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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 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).

Primary outcomes:
measure: Maximum Platelet Aggregation (MPA) to 20 Micromolar (uM) Adenosine Diphosphase (ADP)
timeFrame: 1 week after first dose of randomized study drug
Secondary outcomes:
measure: Maximum Platelet Aggregation (MPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
timeFrame: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug
measure: Maximum Platelet Aggregation (MPA) to 20 uM ADP According to Clopidogrel Use at Time of Qualifying Acute Coronary Syndrome (ACS) Event
timeFrame: End of 14 day open label
measure: Residual Platelet Aggregation (RPA) (to 5 and 20 uM ADP) at 2 Hours, 24 Hours, 1 Week and 2 Weeks
timeFrame: 2 hours, 24 hours, 1 week, 2 weeks after first dose of randomized study drug
measure: 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
timeFrame: 1 week after randomized study drug
measure: Number of Participants With Bleeding Events by Visit According to Thrombolysis in Myocardial Infarction Study Group (TIMI) Criteria
timeFrame: End of 14 day open label (baseline); 24 Hours, 7 days, 14 days after first dose of randomized drug
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Florida
city: Baltimore
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Maryland
city: Worcester
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Massachusetts
city: Ann Arbor
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Michigan
city: Cincinnati
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Ohio
city: Columbus
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Ohio
city: Oklahoma City
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Oklahoma
city: Rapid City
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: South Dakota
city: Houston
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Angiolillo DJ, Saucedo JF, Deraad R, Frelinger AL, Gurbel PA, Costigan TM, Jakubowski JA, Ojeh CK, Effron MB; SWAP Investigators. Increased platelet inhibition after switching from maintenance clopidogrel to prasugrel in patients with acute coronary syndromes: results of the SWAP (SWitching Anti Platelet) study. J Am Coll Cardiol. 2010 Sep 21;56(13):1017-23. doi: 10.1016/j.jacc.2010.02.072.
citation: Saucedo JF, Angiolillo DJ, DeRaad R, Frelinger AL 3rd, Gurbel PA, Costigan TM, Jakubowski JA, Ojeh CK, Duvvuru S, Effron MB; SWAP Investigators. Decrease in high on-treatment platelet reactivity (HPR) prevalence on switching from clopidogrel to prasugrel: insights from the switching anti-platelet (SWAP) study. Thromb Haemost. 2013 Feb;109(2):347-55. doi: 10.1160/TH12-06-0378. Epub 2012 Dec 6.