A Genomic Approach to Warfarin Dose Prescription in Admixed Caribbean Hispanics
NCT02345356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2022-05-19
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
- Atrial Fibrillation
- Deep Vein Thrombosis
- Cardiac Valvular Insufficiency
- Coagulopathies
- Pulmonary Embolism
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
-
Pharmacogenetic Study of Warfarin Dose-Response: a Prospective Trial
NCT00654823 ·Status: UNKNOWN
-
Genotype-Guided Warfarin Therapy Trial
NCT00904293 ·Status: COMPLETED ·Phase: NA
-
Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm
NCT00511173 ·Status: COMPLETED ·Phase: PHASE4
-
Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
NCT00634907 ·Status: COMPLETED ·Phase: NA
-
Genetic Determinants of Warfarin Anticoagulation Effect
NCT00162435 ·Status: UNKNOWN ·Phase: NA
-
Genetic Response to Warfarin in Healthy Subjects
NCT01520402 ·Status: COMPLETED ·Phase: NA
-
VKORC1 and CYP2C9 Gene Polymorphisms and Warfarin Management
NCT00970892 ·Status: UNKNOWN
-
Pharmacogenetic Dosing of Warfarin
NCT02065388 ·Status: COMPLETED ·Phase: PHASE3
-
The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings
NCT00830570 ·Status: COMPLETED
-
PRospective Evaluation Comparing Initiation of Warfarin StrategiEs (PRECISE): Pharmacogenetic-guided Versus Usual Care
NCT00377143 ·Status: WITHDRAWN ·Phase: PHASE4
-
Clinical and Economic Implications of Genetic Testing for Warfarin Management
NCT00964353 ·Status: COMPLETED ·Phase: PHASE4
-
Early Identification of Warfarin Maintenance Dosage
NCT01178034 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacogenetic Dosage Algorithm for Acenocoumarol
NCT03015025 ·Status: COMPLETED
-
Association Between Genetic Variant Scores and Warfarin Effect
NCT03894878 ·Status: COMPLETED
-
Predictors of Anticoagulation Control on Warfarin Therapy
NCT00905177 ·Status: COMPLETED
-
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
NCT01305148 ·Status: SUSPENDED ·Phase: NA
-
Pharmacogenomics of Warfarin in Hispanics and Latinos
NCT02972385 ·Status: RECRUITING
-
Safer Warfarin Treatment
NCT01042067 ·Status: SUSPENDED
-
The Association of Warfarin Dosage and Plasma Enantiomer Concentration With the Gene Polymorphisms of CYP and VKOR
NCT00247702 ·Status: UNKNOWN ·Phase: NA
-
Assessing the Clinical Benefits of a Pharmacogenetics-Guided Dosing Regiment for Calculating Warfarin Maintenance Dose
NCT00700895 ·Status: UNKNOWN ·Phase: PHASE3
-
Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity
NCT02069132 ·Status: UNKNOWN
-
Evaluation of a Pharmacogenetic-based Warfarin Dosing Algorithm in Patients
NCT02592980 ·Status: UNKNOWN ·Phase: PHASE4
-
Genotype-guided Warfarin Individualized Treatment
NCT02211326 ·Status: COMPLETED ·Phase: NA
-
EUropean Pharmacogenetics of AntiCoagulant Therapy - Acenocoumarol
NCT01119261 ·Status: COMPLETED ·Phase: PHASE4
-
Applying Pharmacogenetics to Warfarin Dosing in Chinese Patients
NCT01610141 ·Status: UNKNOWN ·Phase: PHASE4