A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction

Recruiting now

Conditions studied: Coronary Artery Disease

In brief

Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI, occurring in up to 30% of patients. Importantly, these events are associated with poor prognosis. The risk of peri-PCI myocardial infarction/myocardial injury has been in part attributed to HPR. The aim of this study is to prospectively validate the accuracy of the ABCD-GENE score in identifying stable CAD patients undergoing elective PCI treated with standard of care clopidogrel who are at risk of peri-PCI myocardial infarction/myocardial injury. This investigation will be a prospective cohort study conducted in a population of patients (n=500) with stable CAD undergoing elective PCI treated with standard of care clopidogrel. By integrating genetic data with clinical variables, patients will be stratified into 2 cohorts based on their ABCD-GENE score (using a cut-off of 10). Assessments to define HPR status and myocardial infarction/myocardial injury will be performed post-PCI.

Key facts

Study ID

NCT05332262

Run by

University of Florida

People needed

500

Starts

2022-05-23

Expected to finish

2027-08-01

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stable CAD undergoing elective PCI;
• Male or females, Age ≥ 18 years old;
• Troponin negative before PCI*;
• Background of aspirin therapy;
• If troponin is unknown before coronary angiography and no clinical signs of acute coronary syndrome is present, a troponin will not be collected as this is line with standard practice.

You may not qualify if…

• Current presentation with myocardial infarction;
• On treatment with prasugrel or ticagrelor;
• Documented hypersensitivity to clopidogrel;
• Use of an intravenous antiplatelet therapy (i.e., cangrelor or GPI) during PCI;
• Unable to provide written informed consent.

Where it is running

• University of Florida Jacksonville — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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