Cardiovascular Disease (CVD)Early Phase 1NCT03419325
A Genomic Approach for Clopidogrel in Caribbean Hispanics
A Early Phase 1 study testing CYP2C19 test and P2RY12 assay in people with Cardiovascular Disease (CVD) and Stroke, run by University of Puerto Rico at 2 sites in Puerto Rico.
Trial summary
Clopidogrel is a prescription medicine used to minimize blood clot formation in patients with cardiovascular disease, particularly those undergoing heart catheterization and stroke. A substantial amount of medical evidence has proven that patients with stroke or heart diseases can benefit from this medicine. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Disease (CVD), Stroke, Acute Coronary Syndrome
- What is being tested?
- CYP2C19 test and P2RY12 assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- 1 Sep 2020to 30 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caribbean Hispanics (Puerto Ricans, Dominicans or Cubans) residing in Puerto Rico, whose parents are also of Hispanic origin
- Both genders (Males/Females)
- Age ≥21
- Receiving Clopidogrel for therapeutic indications.
- No clinically active hepatic abnormality
- The ability to understand the requirements of the study
- The ability to comply with study procedures and protocol
- A female patient is eligible to enter the study if she is of child-bearing potential and not pregnant or nursing, or not of child-bearing potential
Who cannot join
- Non-Hispanic patients (race/ethnicity is self-reported by the patients)
- Currently enrolled in another active research protocols at the participating institutions
- BUN >30
- Creatinine >2.0 mg/dL
- Platelet count <100,000/mm3
- Nasogastric or enteral feedings
Show all 13Show fewer
- Acute illness (e.g., sepsis, infection, anemia)
- HIV/AIDS, Hepatitis B patients
- Alcoholism and drug abuse
- Patients with any cognitive and mental health impairment
- Sickle cell patients
- Active malignancy
- Patients taking another antiplatelet
Trial locations and contacts
2 sites in 1 country.
Puerto Rico2 sites
University Hospital at Carolina
Carolina, 00984
Cardiovascular Hospital of Puerto Rico and the Caribbean
San Juan, 00926
About this study
Official title: Adopting a Precision Medicine Paradigm in Puerto Rico: Leveraging Ancestral Diversity to Identify Predictors of Clopidogrel Response in Caribbean Hispanics
Clopidogrel is a prescription medicine used to minimize blood clot formation in patients with cardiovascular disease, particularly those undergoing heart catheterization and stroke. A substantial amount of medical evidence has proven that patients with stroke or heart diseases can benefit from this medicine. However, significant variability in such expected benefits has been found among individuals receiving clopidogrel, with some patients not having the benefit of reduced complications and adverse cardiovascular events. Prior studies have demonstrated a significant association between certain variants on patient's genes (e.g., CYP2C19) and poor response to clopidogrel and, therefore, major adverse cardiovascular events. Variation in other genes and other factors such as platelet activation, weight, diabetes mellitus (a medical condition that produces high blood sugar), concomitant use of other drugs, and smoking status have also been proposed to be related to the same adverse outcomes. In this study, the investigators would like to determine a possible association between these genes and the response to the medication among Caribbean Hispanic cardiovascular patients on clopidogrel. In other populations, it is known that patients with certain genetic variants have lower or magnified responses to this medication when compared to those individuals taking the same dose and not carrying the genetic variations. However, a fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics accounts for the observed high inter-individual variability of clinical outcomes to preventive dual antiplatelet therapy (DAPT) with clopidogrel.
Read the detailed description
Despite the substantial work in cardiovascular pharmacogenomics published over the past decade, a fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics accounts for high inter-individual variability of clinical outcomes to preventive dual antiplatelet therapy (DAPT) with clopidogrel. Caribbean Hispanics are disproportionately affected by cardio-metabolic disorders, but with a limited expectation of benefits from existing genomic-based algorithms. The investigators will focus on clopidogrel to develop urgently-needed genomic-driven prescription guidelines for this population. To this purpose, the investigators will implement a treatment algorithm to guide DAPT in Caribbean Hispanics and will create a repository of genomic DNAs and fully annotated clinical and genomic datasets from Caribbean Hispanics with cardiovascular diseases. This proposal will also take a novel approach to definitively assess the admixture component and is also highly practical for the development of a clinical decision support (CDS) tool. The investigators will test the following hypothesis: There are unknown genetic variants that uniquely contribute to clopidogrel responsiveness in Caribbean Hispanics to such extent that a developed CDS tool that incorporates personal ethno-specific genotypes and ex vivo pharmacodynamics (PD) testing will help enable more precise recommendations for optimizing medical outcomes to antiplatelet therapy in this population. To test this hypothesis we will work with the following aim: To implement a treatment algorithm based on ex vivo PD and genetic test results to guide DAPT in Caribbean Hispanics.
This clinical study will be conducted over 2-3 years in 250 naive cardiovascular patients to be treated with DAPT for secondary prevention of thromboembolic events (i.e., to be compared to another set of 250 clopidogrel-treated patients from a matched non-concurrent standard-of-care cohort). It is expected that this study advances the adoption of a Precision Medicine (PM) paradigm for the benefit of Hispanic patients. The richer genetic variance in Latinos is likely to contribute substantially to variability in response to drug treatments, a component that will be missed by traditional studies within homogeneous populations. This addressable oversight is of great concern since it will tend to exacerbate the healthcare disparity already experienced by Hispanic populations in the US. Hispanics have been largely excluded from Precision Medicine initiatives, which increase dramatically the disparities in translating benefits from new findings in pharmacogenomics to this medically underserved population, exacerbating the existing inequity in healthcare services. Accordingly, the proposed research will expand the current understanding of the pharmacogenomics of Clopidogrel. Advancing knowledge in the under-investigated area of pharmacogenetics in minority populations will generate results that apply to personalize DAPT in the wider population as it moves, inevitably, toward increasing heterogeneity through admixed genomes.
- Conditions
- Cardiovascular Disease (CVD), Stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Coronary Artery Disease, Myocardial Infarction
- Being tested
- CYP2C19 test, P2RY12 assay
- Keywords
- percutaneous coronary interventions (PCI), secondary stroke prevention, dual antiplatelet therapy (DAPT)
- Medical subject headings
- Cardiovascular Diseases, Stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP2C19 testGenetic
Patients will be categorized into 4 groups based on the results of their genetic test for CYP2C19 as well as the residual platelet reactivity test (P2RY12 assay=PRU units) and DAPT treatments options will be recommended accordingly (i.e., through a Clinical Decision Support (CDS) tool that is based on a pharmacogenetic-driven algorithm and the PRU result).
P2RY12 assayDiagnostic test
Patients will be categorized into 4 groups based on the results of their genetic test for CYP2C19 as well as the residual platelet reactivity test (P2RY12 assay=PRU units) and DAPT treatments options will be recommended accordingly (i.e., through a Clinical Decision Support (CDS) tool that is based on a pharmacogenetic-driven algorithm and the PRU result).
| Study group | Role | What they receive |
|---|---|---|
| HTPR/LOF | Experimental | Intervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy.
Presence of both high on-treatment platelet reactivity (HTPR) and CYP2C19 loss-of-function (LOF) alleles:
An alternative therapy with either prasugrel or ticagrelor (in line with specific contraindications and precautions for each agent) will be strongly recommended for HPR/LOF patients, within next 5-7 days. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. Receives: Genetic: CYP2C19 test; Diagnostic Test: P2RY12 assay |
| HTPR/no-LOF | Experimental | Intervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy.
Presence of HTPR, but no CYP2C19 LOF allele found:
An alternative therapy should be considered for HTPR/no-LOF patients, within next 5-7 days. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. Receives: Genetic: CYP2C19 test; Diagnostic Test: P2RY12 assay |
| no-HTPR/LOF | Experimental | Intervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy.
Presence of a CYP2C19 LOF allele, but no HTPR:
An alternative therapy should be considered for no-HTPR/LOF patients, within next 5-7 days. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. Receives: Genetic: CYP2C19 test; Diagnostic Test: P2RY12 assay |
| No-HTPR/No-LOF | Experimental | Intervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy.
Absence of both HTPR and CYP2C19 LOF alleles:
Maintaining clopidogrel for no-HPR/no-LOF patients. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. Receives: Genetic: CYP2C19 test; Diagnostic Test: P2RY12 assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE) reductions
MACE reductions will be the composite of all-cause death, MI (according to the universal definition), stroke or coronary revascularization.
Measured: six months after intervention
Secondary outcomes (3)
number of patients with treatment-related cardiovascular (CV) death
death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, CV procedures, CV hemorrhage and other CV causes.
Measured: six months after intervention
number of patients with treatment-related stent thrombosis
definite or confirmed stent thrombosis as proposed by the Academic Research Consortium (ARC): i.e., symptoms suggestive of an acute coronary syndrome and angiographic or pathologic confirmation of stent thrombosis.
Measured: six months after intervention
Bleeding
as defined by Bleeding Academic Research Consortium (BARC) criteria
Measured: six months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Sep 2020
- Primary completion30 Apr 2023
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- After being consented, patients will undergo rapid ex vivo platelet functional testing (i.e., residual platelet reactivity units, PRU, measured using the VerifyNow P2R12 assay for Clopidogrel response) and CYP2C19 genotyping. Patients will then be categorized into 4 groups based on tests results: 1) high on-treatment platelet reactivity (HTPR)/ CYP2C19 loss-of-function (LOF) alleles (i.e., presence of both HTPR and CYP2C19 LOF alleles); 2) HTPR/No-LOF (presence of HTPR, but no CYP2C19 LOF allele); 3) No-HTPR/LOF (presence of a CYP2C19 LOF allele, but no HTPR); 4) No-HTPR/No-LOF (absence of both HTPR and CYP2C19 LOF alleles).
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Jorge Duconge, University of Puerto Rico
- Investigators
- Jorge Duconge, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419325
- Sponsor's protocol ID
- A4070417
- Other IDs
- 2U54MD007600-31
- Status last verified
- May 2026
- First submitted
- 20 Jan 2018
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to voluntarily submit genotyping and phenotype data from this study because there is an expectation that such data can be available for future use in other research projects (i.e., broad research purposes). The investigators will share totally de-identified, individual-level genotype data, obtained from DNA of subjects who have signed informed consent at the respective Institutional Review Board (IRBs), which will fully inform about the risks of studies involving personal genome as specified online (http://grants.nih.gov/grants/gwas/gwas\_ptc.pdf).
Publications
Hernandez-Suarez DF, Melin K, Marin-Maldonado F, Nunez HJ, Gonzalez AF, Gonzalez-Sepulveda L, Rivas-Tumanyan S, Naik H, Ruano G, Scott SA, Duconge J. Implementing a pharmacogenetic-driven algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics: protocol for a non-randomised clinical trial. BMJ Open. 2020 Aug 6;10(8):e038936. doi: 10.1136/bmjopen-2020-038936.
PubMed 32764090Duconge J, Santiago E, Hernandez-Suarez DF, Monero M, Lopez-Reyes A, Rosario M, Renta JY, Gonzalez P, Ileana Fernandez-Morales L, Antonio Velez-Figueroa L, Arce O, Marin-Maldonado F, Nunez H, Melin K, Scott SA, Ruano G. Pharmacogenomic polygenic risk score for clopidogrel responsiveness among Caribbean Hispanics: A candidate gene approach. Clin Transl Sci. 2021 Nov;14(6):2254-2266. doi: 10.1111/cts.13124. Epub 2021 Aug 20.
PubMed 34415683Nunez-Medina H, Monero M, Torres LM, Leal E, Gonzalez-Sepulveda L, Mayor AM, Renta JY, Gonzalez-Garcia ER, Gonzalez A, Melin K, Scott SA, Ruano G, Hernandez-Suarez DF, Duconge J. Implementing a Pharmacogenomic-driven Algorithm to Guide Antiplatelet Therapy among Caribbean Hispanics: A non-randomized prospective cohort study. medRxiv [Preprint]. 2023 Dec 6:2023.12.05.23299547. doi: 10.1101/2023.12.05.23299547.
PubMed 38106133Yang G, Gonzalez P, Monero M, Carrasquillo K, Renta JY, Hernandez-Suarez DF, Botton MR, Melin K, Scott SA, Ruano G, Roche-Lima A, Alarcon C, Ritchie MD, Perera MA, Duconge J. Discovery of Ancestry-specific Variants Associated with Clopidogrel Response among Caribbean Hispanics. medRxiv [Preprint]. 2023 Oct 2:2023.09.29.23296372. doi: 10.1101/2023.09.29.23296372.
PubMed 37873439Monero-Paredes M, Feliu-Maldonado R, Carrasquillo-Carrion K, Gonzalez P, Rogozin IB, Roche-Lima A, Duconge J. Non-Random Enrichment of Single-Nucleotide Polymorphisms Associated with Clopidogrel Resistance within Risk Loci Linked to the Severity of Underlying Cardiovascular Diseases: The Role of Admixture. Genes (Basel). 2023 Sep 17;14(9):1813. doi: 10.3390/genes14091813.
PubMed 37761953Nunez-Medina HJ, Monero M, Torres LM, Leal E, Gonzalez-Sepulveda L, Mayor AM, Renta JY, Gonzalez-Garcia ER, Gonzalez A, Melin K, Scott SA, Ruano G, Hernandez-Suarez DF, Duconge J. Implementing a pharmacogenomic-driven algorithm to guide antiplatelet therapy among Caribbean Hispanics: a non-randomised clinical trial. BMJ Open. 2024 Sep 5;14(9):e084119. doi: 10.1136/bmjopen-2024-084119.
PubMed 39242160
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adopting a Precision Medicine Paradigm in Puerto Rico: Leveraging Ancestral Diversity to Identify Predictors of Clopidogrel Response in Caribbean Hispanics
- ClinicalTrials.gov ID
- NCT03419325
- Acronym / sponsor ID
- A4070417
- Conditions
- Cardiovascular Disease (CVD), Stroke, Acute Coronary Syndrome, Peripheral Arterial Disease, Coronary Artery Disease, Myocardial Infarction
- Keywords
- percutaneous coronary interventions (PCI), secondary stroke prevention, dual antiplatelet therapy (DAPT)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Icahn School of Medicine at Mount Sinai
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clopidogrel is a prescription medicine used to minimize blood clot formation in patients with cardiovascular disease, particularly those undergoing heart catheterization and stroke. A substantial amount of medical evidence has proven that patients with stroke or heart diseases can benefit from this medicine. However, significant variability in such expected benefits has been found among individuals receiving clopidogrel, with some patients not having the benefit of reduced complications and adverse cardiovascular events. Prior studies have demonstrated a significant association between certain variants on patient's genes (e.g., CYP2C19) and poor response to clopidogrel and, therefore, major adverse cardiovascular events. Variation in other genes and other factors such as platelet activation, weight, diabetes mellitus (a medical condition that produces high blood sugar), concomitant use of other drugs, and smoking status have also been proposed to be related to the same adverse outcomes. In this study, the investigators would like to determine a possible association between these genes and the response to the medication among Caribbean Hispanic cardiovascular patients on clopidogrel. In other populations, it is known that patients with certain genetic variants have lower or magnified responses to this medication when compared to those individuals taking the same dose and not carrying the genetic variations. However, a fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics accounts for the observed high inter-individual variability of clinical outcomes to preventive dual antiplatelet therapy (DAPT) with clopidogrel.
Detailed description
Despite the substantial work in cardiovascular pharmacogenomics published over the past decade, a fundamental gap remains in understanding whether the genomic diversity of Caribbean Hispanics accounts for high inter-individual variability of clinical outcomes to preventive dual antiplatelet therapy (DAPT) with clopidogrel. Caribbean Hispanics are disproportionately affected by cardio-metabolic disorders, but with a limited expectation of benefits from existing genomic-based algorithms. The investigators will focus on clopidogrel to develop urgently-needed genomic-driven prescription guidelines for this population. To this purpose, the investigators will implement a treatment algorithm to guide DAPT in Caribbean Hispanics and will create a repository of genomic DNAs and fully annotated clinical and genomic datasets from Caribbean Hispanics with cardiovascular diseases. This proposal will also take a novel approach to definitively assess the admixture component and is also highly practical for the development of a clinical decision support (CDS) tool. The investigators will test the following hypothesis: There are unknown genetic variants that uniquely contribute to clopidogrel responsiveness in Caribbean Hispanics to such extent that a developed CDS tool that incorporates personal ethno-specific genotypes and ex vivo pharmacodynamics (PD) testing will help enable more precise recommendations for optimizing medical outcomes to antiplatelet therapy in this population. To test this hypothesis we will work with the following aim: To implement a treatment algorithm based on ex vivo PD and genetic test results to guide DAPT in Caribbean Hispanics.
This clinical study will be conducted over 2-3 years in 250 naive cardiovascular patients to be treated with DAPT for secondary prevention of thromboembolic events (i.e., to be compared to another set of 250 clopidogrel-treated patients from a matched non-concurrent standard-of-care cohort). It is expected that this study advances the adoption of a Precision Medicine (PM) paradigm for the benefit of Hispanic patients. The richer genetic variance in Latinos is likely to contribute substantially to variability in response to drug treatments, a component that will be missed by traditional studies within homogeneous populations. This addressable oversight is of great concern since it will tend to exacerbate the healthcare disparity already experienced by Hispanic populations in the US. Hispanics have been largely excluded from Precision Medicine initiatives, which increase dramatically the disparities in translating benefits from new findings in pharmacogenomics to this medically underserved population, exacerbating the existing inequity in healthcare services. Accordingly, the proposed research will expand the current understanding of the pharmacogenomics of Clopidogrel. Advancing knowledge in the under-investigated area of pharmacogenetics in minority populations will generate results that apply to personalize DAPT in the wider population as it moves, inevitably, toward increasing heterogeneity through admixed genomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- After being consented, patients will undergo rapid ex vivo platelet functional testing (i.e., residual platelet reactivity units, PRU, measured using the VerifyNow P2R12 assay for Clopidogrel response) and CYP2C19 genotyping. Patients will then be categorized into 4 groups based on tests results: 1) high on-treatment platelet reactivity (HTPR)/ CYP2C19 loss-of-function (LOF) alleles (i.e., presence of both HTPR and CYP2C19 LOF alleles); 2) HTPR/No-LOF (presence of HTPR, but no CYP2C19 LOF allele); 3) No-HTPR/LOF (presence of a CYP2C19 LOF allele, but no HTPR); 4) No-HTPR/No-LOF (absence of both HTPR and CYP2C19 LOF alleles).
| Arm | Type | Receives |
|---|---|---|
| HTPR/LOF | Experimental | Genetic: CYP2C19 test, Diagnostic Test: P2RY12 assayIntervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy. Presence of both high on-treatment platelet reactivity (HTPR) and CYP2C19 loss-of-function (LOF) alleles: An alternative therapy with either prasugrel or ticagrelor (in line with specific contraindications and precautions for each agent) will be strongly recommended for HPR/LOF patients, within next 5-7 days. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. |
| HTPR/no-LOF | Experimental | Genetic: CYP2C19 test, Diagnostic Test: P2RY12 assayIntervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy. Presence of HTPR, but no CYP2C19 LOF allele found: An alternative therapy should be considered for HTPR/no-LOF patients, within next 5-7 days. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. |
| no-HTPR/LOF | Experimental | Genetic: CYP2C19 test, Diagnostic Test: P2RY12 assayIntervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy. Presence of a CYP2C19 LOF allele, but no HTPR: An alternative therapy should be considered for no-HTPR/LOF patients, within next 5-7 days. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. |
| No-HTPR/No-LOF | Experimental | Genetic: CYP2C19 test, Diagnostic Test: P2RY12 assayIntervention: Genotyping (CYP2C19 assay) and P2RY12 testing to make decision on therapy. Absence of both HTPR and CYP2C19 LOF alleles: Maintaining clopidogrel for no-HPR/no-LOF patients. Changes in DAPT will be at the discretion of the clinician. Treatment strategies and clinical outcomes will be evaluated up to 6-months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Caribbean Hispanics (Puerto Ricans, Dominicans or Cubans) residing in Puerto Rico, whose parents are also of Hispanic origin
- Both genders (Males/Females)
- Age ≥21
- Receiving Clopidogrel for therapeutic indications.
- No clinically active hepatic abnormality
Key exclusion criteria (13 listed)
- Non-Hispanic patients (race/ethnicity is self-reported by the patients)
- Currently enrolled in another active research protocols at the participating institutions
- BUN >30
- Creatinine >2.0 mg/dL
- Platelet count <100,000/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYP2C19 testPatients will be categorized into 4 groups based on the results of their genetic test for CYP2C19 as well as the residual platelet reactivity test (P2RY12 assay=PRU units) and DAPT treatments options will be recommended accordingly (i.e., through a Clinical Decision Support (CDS) tool that is based on a pharmacogenetic-driven algorithm and the PRU result). | Genetic | HTPR/LOF, HTPR/no-LOF, No-HTPR/No-LOF, no-HTPR/LOF |
| P2RY12 assayPatients will be categorized into 4 groups based on the results of their genetic test for CYP2C19 as well as the residual platelet reactivity test (P2RY12 assay=PRU units) and DAPT treatments options will be recommended accordingly (i.e., through a Clinical Decision Support (CDS) tool that is based on a pharmacogenetic-driven algorithm and the PRU result). | Diagnostic test | HTPR/LOF, HTPR/no-LOF, No-HTPR/No-LOF, no-HTPR/LOF |
Primary outcome
Major adverse cardiovascular events (MACE) reductions
Time frame: six months after intervention
MACE reductions will be the composite of all-cause death, MI (according to the universal definition), stroke or coronary revascularization.
3 secondary outcomes
number of patients with treatment-related cardiovascular (CV) death
Time frame: six months after intervention
number of patients with treatment-related stent thrombosis
Time frame: six months after intervention
Bleeding
Time frame: six months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 32764090Hernandez-Suarez DF, Melin K, Marin-Maldonado F, Nunez HJ, Gonzalez AF, Gonzalez-Sepulveda L, Rivas-Tumanyan S, Naik H, Ruano G, Scott SA, Duconge J. Implementing a pharmacogenetic-driven algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics: protocol for a non-randomised clinical trial. BMJ Open. 2020 Aug 6;10(8):e038936. doi: 10.1136/bmjopen-2020-038936.
- Results publication: PubMed 34415683Duconge J, Santiago E, Hernandez-Suarez DF, Monero M, Lopez-Reyes A, Rosario M, Renta JY, Gonzalez P, Ileana Fernandez-Morales L, Antonio Velez-Figueroa L, Arce O, Marin-Maldonado F, Nunez H, Melin K, Scott SA, Ruano G. Pharmacogenomic polygenic risk score for clopidogrel responsiveness among Caribbean Hispanics: A candidate gene approach. Clin Transl Sci. 2021 Nov;14(6):2254-2266. doi: 10.1111/cts.13124. Epub 2021 Aug 20.
- Results publication: PubMed 38106133Nunez-Medina H, Monero M, Torres LM, Leal E, Gonzalez-Sepulveda L, Mayor AM, Renta JY, Gonzalez-Garcia ER, Gonzalez A, Melin K, Scott SA, Ruano G, Hernandez-Suarez DF, Duconge J. Implementing a Pharmacogenomic-driven Algorithm to Guide Antiplatelet Therapy among Caribbean Hispanics: A non-randomized prospective cohort study. medRxiv [Preprint]. 2023 Dec 6:2023.12.05.23299547. doi: 10.1101/2023.12.05.23299547.
- Results publication: PubMed 37873439Yang G, Gonzalez P, Monero M, Carrasquillo K, Renta JY, Hernandez-Suarez DF, Botton MR, Melin K, Scott SA, Ruano G, Roche-Lima A, Alarcon C, Ritchie MD, Perera MA, Duconge J. Discovery of Ancestry-specific Variants Associated with Clopidogrel Response among Caribbean Hispanics. medRxiv [Preprint]. 2023 Oct 2:2023.09.29.23296372. doi: 10.1101/2023.09.29.23296372.
- Results publication: PubMed 37761953Monero-Paredes M, Feliu-Maldonado R, Carrasquillo-Carrion K, Gonzalez P, Rogozin IB, Roche-Lima A, Duconge J. Non-Random Enrichment of Single-Nucleotide Polymorphisms Associated with Clopidogrel Resistance within Risk Loci Linked to the Severity of Underlying Cardiovascular Diseases: The Role of Admixture. Genes (Basel). 2023 Sep 17;14(9):1813. doi: 10.3390/genes14091813.
- Derived from this study: PubMed 39242160Nunez-Medina HJ, Monero M, Torres LM, Leal E, Gonzalez-Sepulveda L, Mayor AM, Renta JY, Gonzalez-Garcia ER, Gonzalez A, Melin K, Scott SA, Ruano G, Hernandez-Suarez DF, Duconge J. Implementing a pharmacogenomic-driven algorithm to guide antiplatelet therapy among Caribbean Hispanics: a non-randomised clinical trial. BMJ Open. 2024 Sep 5;14(9):e084119. doi: 10.1136/bmjopen-2024-084119.
- Individual participant dataSharing planned: Yes. The investigators plan to voluntarily submit genotyping and phenotype data from this study because there is an expectation that such data can be available for future use in other research projects (i.e., broad research purposes). The investigators will share totally de-identified, individual-level genotype data, obtained from DNA of subjects who have signed informed consent at the respective Institutional Review Board (IRBs), which will fully inform about the risks of studies involving personal genome as specified online (http://grants.nih.gov/grants/gwas/gwas_ptc.pdf).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Duconge, PhD principal investigator
University of Puerto Rico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CYP2C19 test and P2RY12 assay in people with Cardiovascular Disease (CVD) and Stroke, run by University of Puerto Rico at 2 sites in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) reductions (time frame: six months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03419325, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.