A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
- Conditions
- Coronary Artery Disease
- Interventions
- Diagnostic Test: Assessment of platelet reactivityDiagnostic Test: Troponin measurement
- Registration Number
- NCT05332262
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High ABCD-GENE score (≥10) Troponin measurement 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). High ABCD-GENE score (≥10) Assessment of platelet reactivity 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) Assessment of platelet reactivity 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) Troponin measurement 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).
- Primary Outcome Measures
Name Time Method Peri-PCI myocardial infarction or myocardial injury 24 hours The primary endpoint of the study will be rate of peri-PCI myocardial infarction or myocardial injury, which will be compared between the high ABCD-GENE score cohort and the low ABCD-GENE score cohort.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Florida Jacksonville
🇺🇸Jacksonville, Florida, United States