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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease (CAD)
Drug: Prasugrel
Drug: Clopidogrel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 423
Study Start Date: July 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prasugrel 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
Active Comparator: Clopidogrel Drug: Clopidogrel
75 mg oral daily maintenance dose up to 6 months.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00910299

Locations
United States, Florida
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Clearwater, Florida, United States, 33756
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Jacksonville, Florida, United States, 32209
United States, Georgia
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Rome, Georgia, United States, 30165
United States, Illinois
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Moline, Illinois, United States, 61265
United States, New York
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New York, New York, United States, 10021
United States, Oregon
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Portland, Oregon, United States, 97225
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
United States, South Dakota
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Rapid City, South Dakota, United States, 55701
United States, Tennessee
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Nashville, Tennessee, United States, 37203
Germany
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Bad Berka, Germany, 99437
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Bad Krozingen, Germany, 79189
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Bad Segeberg, Germany, 23795
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Berlin, Germany, 12203
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Bremen, Germany, 28277
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Dortmund, Germany, 44137
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Essen, Germany, 45147
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Freiburg, Germany, 79106
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Fulda, Germany, 36043
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Hamburg, Germany, 20246
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Leipzig, Germany, 04289
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Mainz, Germany, 55131
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Munich, Germany, 80636
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Pforzheim, Germany, 75175
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Stuttgart, Germany, 70376
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Tuebingen, Germany, 72076
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Villingen-Schwenningen, Germany, 78050
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Wuppertal, Germany, 42117
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo Co., Ltd.
Investigators
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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00910299     History of Changes
Other Study ID Numbers: 12323, H7T-MC-TACW
Study First Received: May 28, 2009
Results First Received: April 10, 2012
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Clopidogrel
VerifyNow
PRU Measurements
Drug Eluting Stents (DES)
Heart Disease
Percutaneous Coronary Intervention (PCI)
P2Y12
Platelets
Platelet Reactivity

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Prasugrel
Clopidogrel
Ticlopidine
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014