NCT03419325CompletedEarly phase 1
A Genomic Approach for Clopidogrel in Caribbean Hispanics
Adopting a Precision Medicine Paradigm in Puerto Rico: Leveraging Ancestral Diversity to Identify Predictors of Clopidogrel Response in Caribbean Hispanics
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 20 Jan 2018
- Start date
- 1 Sept 2020
- Primary completion date
- 30 Apr 2023
- Lead sponsor
- University of Puerto Rico
- Diseases
- Coronary artery disease, Stroke
- NCT number
- NCT03419325
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 150
- From 1 Sept 2020 to the primary completion date, 30 Apr 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcoholism and drug abuse
Other illness
- Acute illness (e.g., sepsis, infection, anemia)
- HIV/AIDS, Hepatitis B patients
- Patients with any cognitive and mental health impairment
- Active malignancy
Lab values
- Creatinine \>2.0 mg/dL
- Platelet count \<100,000/mm3
Other
- Non-Hispanic patients (race/ethnicity is self-reported by the patients)
- Currently enrolled in another active research protocols at the participating institutions
- BUN \>30
- Nasogastric or enteral feedings
- Sickle cell patients
- Patients taking another antiplatelet
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital at Carolina Coordinator of this site? Confirm its status | Carolina | Puerto Rico | Unknown status |
| Cardiovascular Hospital of Puerto Rico and the Caribbean Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.