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Patients Undergoing Percutaneous Coronary Intervention (PCI) Through Optimal Platelet Inhibition (TRIAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01582217
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : December 23, 2015
Daiichi Sankyo, Inc.
Accumetrics, Inc.
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.

Condition or disease
Percutaneous Coronary Intervention Dual Antiplatelet Therapy Aspirin Clopidogrel

Detailed Description:
Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).

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Study Type : Observational
Actual Enrollment : 318 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition
Study Start Date : March 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

SA + 5mg prasugrel
Prasugrel 5 mg group: Patients with Intermediate or high bleeding risks and PRU ≥ 230 are Prescribed 5mg of prasugrel daily along with aspirin.
ASA + 10 mg prasugrel
Prasugrel 10 mg group: Patients with Low bleeding risk and high ischemia risk and PRU ≥ 230 are prescribed 10 mg of prasugrel daily along with aspirin.
ASA + 75 mg clopidogrel daily
Clopidogrel 75 mg group (control): PRU ≤ 230; high bleeding risk or high ischemic risk; patients with active malignancy, age >75; Wt< 60kg with previous CVA or TA are prescribed 75 mg of clopidogrel daily along with aspirin.

Primary Outcome Measures :
  1. MACE [ Time Frame: 12 months ]
    Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)

Secondary Outcome Measures :
  1. Rates of major bleeding [ Time Frame: 12 months ]
    The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects in any of the participating sites who are on chronic clopidogrel treatment and return for PCI will be considered for this study.

Inclusion Criteria:

  • The subject has provided informed written.
  • The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
  • Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
  • The subject is willing and able to cooperate with the study procedures and required follow-ups.

Exclusion Criteria:

  • Patients with cardiogenic shock will be excluded.
  • The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
  • Pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01582217

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United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Daiichi Sankyo, Inc.
Accumetrics, Inc.
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Principal Investigator: George Dangas, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT01582217    
Other Study ID Numbers: GCO 12-0028
FWA # 00005656 and 00005651
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by Icahn School of Medicine at Mount Sinai:
Risk Score