Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)

Condition(s) targeted: Coronary Artery Disease (CAD)

Intervention: Prasugrel (Drug); Clopidogrel (Drug)

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 1-317-615-4559 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) or, Phone: 1-317-615-4559

To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting stents.

To determine the adverse event profile of prasugrel in patients with high platelet reactivity on clopidogrel after implantation of coronary drug-eluting stents.

To determine the effect of prasugrel on inhibition of platelet activation in patients with high platelet reactivity on clopidogrel.

Official title: Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent

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

Primary outcome: The time to first occurrence of heart attack or cardiovascular death.

Secondary outcome:

The time to first occurrence of stent thrombosis.

The time to first occurrence of all-cause death or myocardial infarction.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Have coronary artery disease and clinical indication for percutaneous coronary

intervention with implantation of at least one drug-eluting stent and where percutaneous coronary intervention of all treated lesions is successful

- Have been given standard-of-care clopidogrel 600-mg loading dose between 6 hours

before and at the time of percutaneous coronary intervention

- Standard of Care Aspirin use prior to percutaneous coronary intervention; at least

300-mg nonenteric-coated oral aspirin at least 6 hours prior to procedure or aspirin greater than or less than 300 mg chewed or as effervescent tablet or 250- to 500-mg intravenous aspirin at least 30 min. prior to procedure

- VerifyNow P2Y12 reaction units > 208, measured 2-4 hours after first clopidogrel

maintenance dose following successful percutaneous coronary intervention

Exclusion Criteria:

- Non-ST segment elevation myocardial infarction within 14 days prior to randomization

- ST-segment elevation myocardial infarction within 14 days prior to randomization

- Have known major complications after percutaneous coronary intervention and prior to

randomization

- Have a body weight < 60 kg

- Have cardiogenic shock at time of randomization

- Have refractory ventricular arrhythmias

- Have New York Heart Association Class IV congestive heart failure

- Have received GP IIb/IIIa inhibitors eptifibatide or tirofiban within 24 hrs before

or during percutaneous coronary intervention or abciximab within 10 days before or during percutaneous coronary intervention

- Are receiving daily treatment with NSAIDs or COX2 inhibitors that cannot be

discontinued or are anticipated to require > 2 weeks of daily treatment during the study

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

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., Duisburg 47137, Germany; Not yet 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., Ludwigshafen D-67063, Germany; Not yet 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., Mainz 55101, Germany; Not yet 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., Muenchen D-81737, Germany; Not yet 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., Bad Krozingen 79189, Germany; 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., Bad Segeberg 23795, Germany; 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., Berlin D-12200, Germany; 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., Dortmund 44137, Germany; 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., Freiburg 79106, Germany; 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., Leipzig 04289, Germany; 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., Munchen D-80636, Germany; 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., Neuss 41464, Germany; 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., Tuebingen 72076, Germany; 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., Villingen-Schwenningen 78050, Germany; Recruiting
Eli Lilly

Starting date: July 2009
Ending date: May 2011
Last updated: August 17, 2009