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

This study has been terminated.
(Due to the low rate of primary endpoint events experienced in the study to date)
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00910299
First received: May 28, 2009
Last updated: May 8, 2012
Last verified: April 2012

May 28, 2009
May 8, 2012
July 2009
April 2011   (final data collection date for primary outcome measure)
Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
The endpoint in this measure is a combination of cardiovascular death or MI.
The time to first occurrence of heart attack or cardiovascular death. [ Time Frame: Through 6 months. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00910299 on ClinicalTrials.gov Archive Site
  • Number of Participants With Stent Thrombosis (ST) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
    Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.
  • Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI) [ Time Frame: Baseline through 6 months ] [ Designated as safety issue: No ]
    The endpoint in this measure is a combination of all-cause death or MI.
  • The time to first occurrence of stent thrombosis. [ Time Frame: Through 6 months. ] [ Designated as safety issue: No ]
  • The time to first occurrence of all-cause death or myocardial infarction. [ Time Frame: Through 6 months. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
Effectiveness of Prasugrel Versus Clopidogrel in Subjects With High Platelet Reactivity on Clopidogrel Following Elective Percutaneous Coronary Intervention With Implantation of Drug-Eluting Stent

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease (CAD)
  • Drug: Prasugrel
    One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.
    Other Names:
    • LY640315
    • Effient
    • Efient
  • Drug: Clopidogrel
    75 mg oral daily maintenance dose up to 6 months.
  • Experimental: Prasugrel
    Intervention: Drug: Prasugrel
  • Active Comparator: Clopidogrel
    Intervention: Drug: Clopidogrel
Trenk D, Stone GW, Gawaz M, Kastrati A, Angiolillo DJ, Müller U, Richardt G, Jakubowski JA, Neumann FJ. A randomized trial of prasugrel versus clopidogrel in patients with high platelet reactivity on clopidogrel after elective percutaneous coronary intervention with implantation of drug-eluting stents: results of the TRIGGER-PCI (Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel) study. J Am Coll Cardiol. 2012 Jun 12;59(24):2159-64. doi: 10.1016/j.jacc.2012.02.026. Epub 2012 Apr 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
423
April 2011
April 2011   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Have coronary artery disease and clinical indication for percutaneous coronary intervention (PCI) 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 24 hours before and at the time of PCI.
  • Standard of Care Aspirin use prior to PCI - at least 250-mg [intravenous (IV) or oral] within 24 hours before PCI and at the time of PCI.
  • VerifyNow P2Y12 reaction units > 208 measured 2-7 hours after clopidogrel maintenance dose the day after successful PCI.

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 kilogram (kg)
  • Have cardiogenic shock at time of randomization
  • Have refractory ventricular arrhythmias
  • Have New York Heart Association Class IV congestive heart failure
  • Have received glycoprotein (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 nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require > 2 weeks of daily treatment during the study
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00910299
12323, H7T-MC-TACW
Yes
Eli Lilly and Company
Eli Lilly and Company
Daiichi Sankyo Co., Ltd.
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP