Status:
ACTIVE_NOT_RECRUITING
A Genomic Approach for Clopidogrel in Caribbean Hispanics
Lead Sponsor:
University of Puerto Rico
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Icahn School of Medicine at Mount Sinai
Conditions:
Cardiovascular Disease (CVD)
Stroke
Eligibility:
All Genders
21+ years
Phase:
EARLY_PHASE1
Brief 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 amou...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03419325
Start Date
September 1 2020
End Date
December 30 2024
Last Update
June 26 2024
Active Locations (2)
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1
University Hospital at Carolina
Carolina, Puerto Rico, 00984
2
Cardiovascular Hospital of Puerto Rico and the Caribbean
San Juan, Puerto Rico, 00926