Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05332262

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Assessment of platelet reactivity

Troponin measurement

Study Details

Brief summary:

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.

Conditions

Coronary Artery Disease

Study ID

NCT05332262

Start date

May 23, 2022

Status verified date

Jan, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Stable CAD undergoing elective PCI;
2. Male or females, Age ≥ 18 years old;
3. Troponin negative before PCI\*;
4. 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.

Exclusion criteria:

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

High ABCD-GENE score (≥10)

All patients in this cohort will have an ABCD-GENE score ≥10 and will be receiving clopidogrel following PCI as per standard of care.

The ABCD-GENE score encompasses a total of 5 variables: 4 clinical (age, body mass index, chronic kidney disease status, and diabetes mellitus) and 1 genetic (CYP2C19 LOF).

Low ABCD-GENE score (<10)

All patients in this cohort will have an ABCD-GENE score <10 and will be receiving clopidogrel following PCI as per standard of care.

The ABCD-GENE score encompasses a total of 5 variables: 4 clinical (age, body mass index, chronic kidney disease status, and diabetes mellitus) and 1 genetic (CYP2C19 LOF).

Interventions

Assessment of platelet reactivity

Assessment of platelet reactivity and HPR status will be performed post-PCI. Platelet reactivity will be measured by VerifyNow P2Y12 and HPR status will be defined using a cut-off value of platelet reactivity units (PRU)>208.

Troponin measurement

Measurement of high sensitivity troponin for the assessment for the presence of myocardial infarction/myocardial injury will be performed post-PCI.

Primary outcome measure

  • Peri-PCI myocardial infarction or myocardial injury [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Francesco Franchi, MD

9042442060francesco.franchi@jax.ufl.edu

Andrea Burton

9042445617Andrea.Burton@jax.ufl.edu

Locations

University of Florida Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

More Information

Sponsor

University of Florida

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • percutaneous coronary intervention
  • clopidogrel
  • high platelet reactivity
  • myocardial injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-01-20.