NCT00910299

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Geographic Reach
2 countries

27 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 8, 2012

Completed
Last Updated

June 8, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

May 28, 2009

Results QC Date

April 10, 2012

Last Update Submit

May 8, 2012

Conditions

Coronary Artery Disease (CAD)

Keywords

ClopidogrelVerifyNowPRU MeasurementsDrug Eluting Stents (DES)Heart DiseasePercutaneous Coronary Intervention (PCI)P2Y12PlateletsPlatelet Reactivity

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)

    The endpoint in this measure is a combination of cardiovascular death or MI.

    Baseline through 6 months

Secondary Outcomes (2)

  • Number of Participants With Stent Thrombosis (ST)

    Baseline through 6 months

  • Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)

    Baseline through 6 months

Study Arms (2)

Prasugrel

EXPERIMENTAL
Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR
Drug: Clopidogrel

Interventions

PrasugrelDRUG

One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months.

Also known as: LY640315, Effient, Efient
Prasugrel
ClopidogrelDRUG

75 mg oral daily maintenance dose up to 6 months.

Clopidogrel

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

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.

Clearwater, Florida, 33756, United States

Location

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Jacksonville, Florida, 32209, United States

Location

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Rome, Georgia, 30165, United States

Location

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Moline, Illinois, 61265, United States

Location

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New York, New York, 10021, United States

Location

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Portland, Oregon, 97225, United States

Location

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Pittsburgh, Pennsylvania, 15213, United States

Location

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Rapid City, South Dakota, 55701, United States

Location

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Nashville, Tennessee, 37203, United States

Location

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Bad Berka, 99437, Germany

Location

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Bad Krozingen, 79189, Germany

Location

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Bad Segeberg, 23795, Germany

Location

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Berlin, 12203, Germany

Location

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Bremen, 28277, Germany

Location

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Dortmund, 44137, Germany

Location

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Essen, 45147, Germany

Location

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Freiburg im Breisgau, 79106, Germany

Location

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Fulda, 36043, Germany

Location

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Hamburg, 20246, Germany

Location

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Leipzig, 04289, Germany

Location

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Mainz, 55131, Germany

Location

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Munich, 80636, Germany

Location

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Pforzheim, 75175, Germany

Location

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Stuttgart, 70376, Germany

Location

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Tübingen, 72076, Germany

Location

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Villingen-Schwenningen, 78050, Germany

Location

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Wuppertal, 42117, Germany

Location

Related Publications (1)

  • Trenk D, Stone GW, Gawaz M, Kastrati A, Angiolillo DJ, Muller 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.

    PMID: 22520250DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Diseases

Interventions

Prasugrel HydrochlorideClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study was terminated early, and no formal statistical time-to-event analysis was performed.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

June 8, 2012

Results First Posted

June 8, 2012

Record last verified: 2012-04

Locations

DE(18)US(9)