Evidence map›Paper›PMID 39242160›Full record

Trial reportBMJ open2024

Implementing a pharmacogenomic-driven algorithm to guide antiplatelet therapy among Caribbean Hispanics: a non-randomised clinical trial.

Hector J Nuñez-Medina, Mariangeli Monero, Lorna M Torres, Enrique Leal, Lorena Gonzalez-Sepulveda, Ángel M Mayor, Jessicca Y Renta, Edgardo R González-García, Ariel González, Kyle Melin and 4 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03419325 (Adopting a Precision Medicine Paradigm in Puerto Rico), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03419325 early_phase1completednot on this map

Adopting a Precision Medicine Paradigm in Puerto Rico: Leveraging Ancestral Diversity to Identify Predictors of Clopidogrel Response in Caribbean Hispanics

TypeinterventionalSponsorUniversity of Puerto RicoRan2020 to 2025Enrolled150ConditionsCardiovascular Disease (CVD), Stroke, Acute Coronary Syndrome, Peripheral Arterial DiseaseArmsCYP2C19 test, P2RY12 assay
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Hector J Nuñez-Medina *Division of Cardiovascular Medicine, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Mariangeli Monero *Department of Pharmacology, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Lorna M TorresDivision of Cardiovascular Medicine, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Enrique LealDivision of Cardiovascular Medicine, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Lorena Gonzalez-SepulvedaBiostatistics, Epidemiology, and Research Design Core, Hispanic Alliance for Clinical and Translational Research, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Ángel M MayorBiostatistics, Epidemiology, and Research Design Core, Hispanic Alliance for Clinical and Translational Research, Universidad Central Del Caribe, Bayamon, Puerto Rico, USA.
Jessicca Y RentaResearch Centers in Minority Institutions (RCMI) Program, Center for Collaborative Research in Health Disparities (CCRHD), University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Edgardo R González-GarcíaDivision of Cardiovascular Medicine, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Ariel GonzálezDivision of Cardiovascular Medicine, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.
Kyle MelinDepartment of Pharmacy Practice, School of Pharmacy, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.ORCID 0000-0002-4698-8021
Stuart A ScottDepartment of Pathology, Stanford University, Stanford, California, USA.
Gualberto RuañoHartford Hospital Institute of Living, Hartford, Connecticut, USA.
Dagmar F Hernandez-SuarezMiami Cardiac and Vascular Institute, Baptist Health South Florida, Miami, Florida, USA.
Jorge DucongeDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA jorge.duconge@upr.edu.ORCID 0000-0002-5955-3449

Funding

SCIENCE AND TECHNOLOGY COMPETENCY & EDUCATION CORE (STCE)P20GM103475 · NIGMS · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI Jose R. Rodriguez-Medina · 2012 to 2026
$52.9M
Upstream Regulation and Downstream effectors of c-MYC in Ovarian CancerU54MD007600 · NIMHD · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI Souhail M Malave-Rivera · 2017 to 2026
$35.8M
RISE Option III: MBRS RISE at the UPR Medical Sciences CampusR25GM061838 · NIGMS · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI CADILLA, CARMEN LYDIA · 2000 to 2021
$25.5M
Tracking and Evaluation CoreU54GM133807 · NIGMS · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI PORTER, JAMES T. · 2020 to 2024
$17.7M
Hispanic Clinical and Translational Research Education and Career Development ProgramR25MD007607 · NIMHD · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI Karen G. Martinez Gonzalez, Barbara Segarra-Vazquez · 2012 to 2026
$7.4M
Merging artificial intelligence (AI) and pharmacometrics to elucidate gene-drug interactions linked to clopidogrel responsiveness in genetically heterogeneous patientsR16GM149372 · NIGMS · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI Jorge Duconge · 2023 to 2026
$596k
NIGMS NIH HHS P20 GM103475NIGMS NIH HHS R16 GM149372NIGMS NIH HHS R25 GM061838NIGMS NIH HHS U54 GM133807NIMHD NIH HHS R25 MD007607NIMHD NIH HHS U54 MD007600
6 · The paper itself

Abstract

objectivesTo assess whether genotype-guided selection of oral antiplatelet drugs using a clinical decision support (CDS) algorithm reduces the rate of major adverse cardiovascular and cerebrovascular events (MACCEs) among Caribbean Hispanic patients, after 6 months.

designAn open-label, multicentre, non-randomised clinical trial.

settingEight secondary and tertiary care hospitals (public and private) in Puerto Rico.

participants300 Caribbean Hispanic patients on clopidogrel, both genders, underwent percutaneous coronary intervention (PCI) for acute coronary syndromes, stable ischaemic heart disease and documented extracardiac vascular diseases.

interventionsPatients were separated into standard-of-care (SoC) and genotype-guided (pharmacogenetic (PGx)-CDS) groups (150 each) and stratified by risk scores. Risk scores were calculated based on a previously developed CDS risk prediction algorithm designed to make actionable treatment recommendations for each patient. Individual platelet function, genotypes, clinical and demographic data were included. Ticagrelor was recommended for patients with a high-risk score ≥2 in the PGx-CDS group only, the rest were kept or de-escalated to clopidogrel. The intervention took place within 3-5 days after PCI. Adherence medication score was also measured. PRIMARY AND SECONDARY OUTCOMES: The occurrence rate of MACCEs (primary) and bleeding episodes (secondary). Statistical associations between patient time free of events and predictor variables (ie, treatment groups, risk scores) were tested using Kaplan-Meier survival analyses and Cox proportional-hazards regression models.

resultsThe genotype-guided group had a clinically lower but not significantly different risk of MACCEs compared with the SoC group (8.7% vs 10.7%, p=0.56; HR=0.56). Among high-risk score patients, genotype-driven guidance of antiplatelet therapy showed superiority over SoC in reducing MACCE incidence 6 months postcoronary stenting (adjusted HR=0.104; p< 0.0001).

conclusionsThe potential benefit of implementing our PGx-CDS algorithm to significantly reduce the incidence rate of MACCEs in post-PCI Caribbean Hispanic patients on clopidogrel was observed exclusively among high-risk patients, with apparently no evident effect in other patient groups. TRIAL REGISTRATION NUMBER: NCT03419325.

Indexed as

AlgorithmsClopidogrelHispanic or LatinoPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsTicagrelorAcute Coronary SyndromeAgedCaribbean RegionCytochrome P-450 CYP2C19Decision Support Systems, ClinicalFemaleGenotypeHemorrhageHumansMaleClopidogrelCytochrome P-450 CYP2C19Platelet Aggregation InhibitorsTicagreloradverse eventscardiovascular diseaseclinical decision-makinggeneticsrisk factors

Identifiers

PMID39242160
PMCPMC11381646

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.