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Completed

NCT Number: NCT01582217

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

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.

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Key information

Conditions

Percutaneous Coronary Intervention Aspirin Clopidogrel Dual Antiplatelet Therapy Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Medical Center

New York, 10029, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. MACE

    Time frame: 12 months

    Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Accumetrics, Inc.
  • Daiichi Sankyo

Registry information

Official study title

TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition

Acronym: TRIAGE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2012
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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