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Implementing a pharmacogenetic-driven algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics:
Dagmar F Hernandez-Suarez1, Kyle Melin2, Frances Marin-Maldonado3
1Division of Cardiovascular Medicine, University of Puerto Rico School of Medicine, Medical Sciences Campus, San Juan, Puerto Rico, USA.
Insights
This study tests if genetic-guided antiplatelet therapy improves outcomes for Hispanic patients after PCI. It compares this approach to standard care, focusing on major adverse cardiovascular events.
Area of Science:
- Pharmacogenomics
- Cardiovascular Medicine
- Clinical Trials
Background:
- Minority populations, including Hispanics, face higher cardiovascular disease burdens.
- CYP2C19 variants affect clopidogrel response in patients with coronary artery disease (CAD) or acute coronary syndrome (ACS) post-percutaneous coronary intervention (PCI).
- Limited research exists on CYP2C19 genotyping and antiplatelet therapy outcomes in Hispanic populations.
Purpose of the Study:
- To evaluate the safety and efficacy of a pharmacogenomic-guided algorithm for dual antiplatelet therapy (DAPT) in Caribbean Hispanic patients.
- To determine if genetic-guided DAPT is superior to standard-of-care clopidogrel therapy.
- To assess the safety of continuing clopidogrel in low-risk patients versus escalating therapy in high-risk patients.
Main Methods:
- A multicentre, prospective, non-randomised clinical trial involving 250 Hispanic patients post-PCI.
- Comparison with a matched non-concurrent cohort of 250 patients receiving standard clopidogrel therapy.
- Assessment of major adverse cardiovascular events (MACEs) including death, MI, stroke, revascularisation, stent thrombosis, and bleeding over 6 months.
Main Results:
- This is a pre-results abstract; specific findings are not yet available.
- The study aims to provide data on the effectiveness of personalized antiplatelet therapy in a specific minority group.
- Recruitment is ongoing until the target patient groups are complete.
Conclusions:
- The study is expected to provide crucial insights into personalized antiplatelet strategies for Hispanic populations.
- Findings may inform clinical practice guidelines for DAPT in this underrepresented group.
- This research addresses a significant gap in pharmacogenomic research for cardiovascular care.
Introduction:
Minority populations in the USA are disproportionately affected by cardiovascular conditions. Reduced responsiveness to clopidogrel among carriers of CYP2C19 variants has been reported in patients with either coronary artery disease (CAD) or acute coronary syndrome (ACS) after the percutaneous coronary intervention (PCI). Previous studies have evaluated CYP2C19 genotyping-guided antiplatelet therapy in selected populations; however, this has yet to be tested among Hispanics. Given the paucity of clinical research on CYP2C19 and antiplatelet clinical outcomes in Hispanics, our study will test the safety and efficacy of a genetic-driven treatment algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics.
Methods And Analysis:
This is a multicentre, prospective, non-randomised clinical trial that proposes an assessment of pharmacogenomic-guided DAPT in post-PCI Caribbean Hispanic patients with ACS or CAD. We will recruit 250 patients to be compared with a matched non-concurrent cohort of 250 clopidogrel-treated patients (standard-of-care). Major adverse cardiovascular events (MACEs) such as all-cause death, myocardial infarction (MI), stroke, coronary revascularisation, stent thrombosis and bleedings over 6 months will be the study endpoints. Among the recruited, high-risk patients will be escalated to ticagrelor and low-risk patients will remain on clopidogrel. The primary objective is to determine whether genetic-guided therapy is superior to standard of care. The secondary objective will determine if clopidogrel treatment in low-risk patients is not associated with a higher rate of MACEs compared with escalated antiplatelet therapy in high-risk patients. Patients will be enrolled up to the group's completion.
Ethics And Dissemination:
Approval was obtained from the Institutional Review Board of the University of Puerto Rico Medical Sciences Campus (protocol # A4070417). The study will be carried out in compliance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice Guidelines. Findings will be published in a peer-reviewed journal and controlled access to experimental data will be available.
Trial Registration Number:
NCT03419325; Pre-results.
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