A Genomic Approach to Warfarin Dose Prescription in Admixed Caribbean Hispanics

NCT02345356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-05-19

No results posted yet for this study

Summary

Caribbean Hispanics are a population with a disproportionately high prevalence of cardio-metabolic disorders but with a limited expectation of benefits from current pharmacogenetic algorithms derived mainly in subjects of relatively pure ancestry. The investigators focus on warfarin responses to develop urgently-needed DNA-driven prescription guidelines for this population, who have arisen from European, West African and Amerindian genomic origins to produce a highly heterogeneous population. Our project combines admixture analysis and DNA-sequencing with development of more accurate rules for better predictability of warfarin dosing to immediately serve this medically underserved population.

Conditions

Interventions

GENETIC

Genotype-guided

Individual warfarin dose adjustments by using a pharmacogenetically driven algorithm

OTHER

Standard-of-Care

Individual warfarin dose adjustments by using a clinically driven algorithm (standard care)

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • Genomas, Inc

    collaborator INDUSTRY
  • University of Puerto Rico

    lead OTHER

Principal Investigators

  • Jorge Duconge, PhD · University of Puerto Rico Medical Sciences Campus

  • Graciela M. Vega-Debien, BSc · University of Puerto Rico Medical Sciences Campus

  • Angel Lopez-Candales, MD · University of Puerto Rico Medical Sciences Campus

  • Alga S. Ramos, PharmD · Miami VA Hospital

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-05-17
Completion
2022-05-17

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345356 on ClinicalTrials.gov