Implementing a pharmacogenetic-driven algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics: protocol for a non-randomised clinical trial
| Autor: | Stuart A. Scott, Frances Marin-Maldonado, Dagmar F. Hernandez-Suarez, Gualberto Ruaño, Hetanshi Naik, Sona Rivas-Tumanyan, Kyle Melin, Jorge Duconge, Lorena González-Sepúlveda, Hector J Nunez, Ariel F. Gonzalez |
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| Rok vydání: | 2020 |
| Předmět: |
Acute coronary syndrome
medicine.medical_treatment Coronary artery disease Percutaneous Coronary Intervention medicine Clinical endpoint Humans genetics cardiovascular diseases Prospective Studies Acute Coronary Syndrome coronary heart disease business.industry Percutaneous coronary intervention Genetics and Genomics General Medicine Hispanic or Latino Clopidogrel medicine.disease Institutional review board Clinical trial Treatment Outcome Caribbean Region Pharmacogenetics Medicine coronary intervention clinical pharmacology business Ticagrelor Algorithm Prasugrel Hydrochloride Algorithms Dinucleoside Phosphates Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | BMJ Open BMJ Open, Vol 10, Iss 8 (2020) |
| ISSN: | 2044-6055 |
| Popis: | IntroductionMinority populations in the USA are disproportionately affected by cardiovascular conditions. Reduced responsiveness to clopidogrel among carriers ofCYP2C19variants 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 evaluatedCYP2C19genotyping-guided antiplatelet therapy in selected populations; however, this has yet to be tested among Hispanics. Given the paucity of clinical research onCYP2C19and 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 analysisThis 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 disseminationApproval 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 numberNCT03419325; Pre-results. |
| Databáze: | OpenAIRE |
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