TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Percutaneous Coronary Intervention
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 318
- Locations
- 1
- Primary Endpoint
- MACE
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
MACE
Time Frame: 12 months
Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)
Secondary Outcomes
- Rates of major bleeding(12 months)