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

TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes 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.

Study Overview

• Status: Completed
• Conditions: Aspirin; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy; 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).

• Study Type: Observational
• Enrollment (Actual): 318

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of major bleeding	The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.	12 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Daiichi Sankyo, Inc.; Accumetrics, Inc.
• Investigators: Principal Investigator: George Dangas, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Prasugrel; Outcomes; Bleeding; Risk Score
• Other Study ID Numbers: GCO 12-0028; FWA # 00005656 and 00005651