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

Icahn School of Medicine at Mount Sinai318 enrolled

Overview

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.

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

318

Conditions

Percutaneous Coronary Intervention Dual Antiplatelet Therapy Aspirin Clopidogrel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mount Sinai Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

MACE

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

Time frame: 12 months

Secondary Outcomes

Rates of major bleeding

The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.

Time frame: 12 months

Data from ClinicalTrials.gov

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