Clinical trial NCT05332262: A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
Official title: Ability of a Precision Medicine Approach to Identify Stable CAD Patients Undergoing Elective PCI Who Are at Risk of Peri-PCI Myocardial Infarction/Myocardial Injury: The ABCD-Gene Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: percutaneous coronary intervention
clopidogrel
high platelet reactivity
myocardial injury
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All-comers population of troponin-negative CAD patients undergoing elective PCI as part of their standard of care at the Division of Cardiology of University of Florida Health, Jacksonville, Florida. Genotyping will be performed as per standard of care in the UF Health Pathology lab.

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.

Detailed description: Antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone of treatment for patients undergoing percutaneous coronary intervention (PCI). Clopidogrel is the recommended P2Y12 inhibitor in patients with stable coronary artery disease (CAD) undergoing elective PCI. However, clopidogrel effects are subject to variability and 30-40% of patients have high platelet reactivity (HPR), which translates into higher rates of thrombotic complications. 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 investigators recently developed a precision medicine tool integrating clinical and genetic factors called ABCD-GENE able to identify HPR status. This score helps characterize patients at risk for peri-PCI thrombotic complications, who can thus potentially benefit from changes in antiplatelet treatment regimen. However, the ABCD-GENE score was generated through retrospective assessments, thus warranting prospective validation. The high frequency of elective PCI procedures and the prevalence with which myocardial infarction/myocardial injury occurs underscore the need for tools that can better identify patients at risk so that therapeutic measures can be implemented to improve their prognosis. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peri-PCI myocardial infarction or myocardial injury
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
Study officials:
affiliation: University of Florida College of Medicine Jacksonville
name: Francesco Franchi, MD
role: PRINCIPAL_INVESTIGATOR
References: