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

Completed

• Conditions: Dual Antiplatelet Therapy; Aspirin; Percutaneous Coronary Intervention; Clopidogrel

• Registration Number: NCT01582217
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	12 months	Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)

Secondary Outcome Measures

Name	Time	Method
Rates of major bleeding	12 months	The rates of major bleeding in patients treated with a thienopyridine based on the clinical algorithm.

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States