CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Genotype-guided +1 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02345356
NCT02345356N/ACompleted

A Randomized, Double-blind Clinical Trial of Anticoagulation Therapy With Warfarin in Caribbean Hispanics: Comparison Between an Admixture-adjusted Pharmacogenetic-driven Warfarin Dose Refinement Algorithm and the Standard of Care

University of Puerto Rico·observational·Posted Jan 26, 2015·Updated May 19, 2022

In Brief

An observational study evaluating Genotype-guided and Standard-of-Care for Atrial Fibrillation and 4 related conditions. Completed, enrolled 200 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartJan 1, 2016
Primary CompletionMay 17, 2022
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 11.4 years ago

Interventions

Genotype-guidedgenetic

Individual warfarin dose adjustments by using a pharmacogenetically driven algorithm

Standard-of-Careother

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