CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 350 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01318057
NCT01318057N/ACompleted

Pharmacogenetics of Warfarin in Puerto Rican Patients Using a Physiogenomics Approach.

University of Puerto Rico·observational·Posted Mar 18, 2011·Updated Jan 21, 2015

In Brief

An observational study for Atrial Fibrillation and 4 related conditions. Completed, enrolled 350 participants across 1 site.

Detailed Summary

Warfarin (Coumadin) is a prescribed "blood thinner" medication used to make the blood less thick in people with high risk of forming blood clots. Despite the various methods to monitor this drug, life-threatening bleeding is a common undesired effect and might result in patient death. Patients starting warfarin therapy may require several weeks or even months to reach the appropriate blood level of warfarin. This blind practice could place the patient at high risk. There are several demographic and clinical factors that significantly influence how much warfarin the patient needs to attain the desired response. Genes, which control hereditary traits, are also important. Now, the investigators know that by using the information encoded in patient's genes the investigators are able to individualize the therapy. Two genes are considered to be involved in warfarin response (CYP2C9 and VKORC1). This study proposes to ascertain what CYP2C9 and VKORC1 variants are present in warfarin-treated Puerto Rican patients. To this purpose, a novel physiogenomic array comprising 384 variants in 222 genes of cardio-metabolic relevance will be used so the investigators are able to determine the structure of the Puerto Rican population in terms of ancestral contributions and how the admixture may impact the prevalence of CYP2C9 and VKORC1 variants. Secondly, the investigators will assess the association of these variants to clinical responses in order to develop a better method of dose estimation. The expected result is the improvement of warfarin therapy in Puerto Ricans. The proposed study will fill a gap in the knowledge of warfarin pharmacogenetics, providing new information on the prevalence of CYP2C9 (metabolism) and VKORC1 (sensitivity) polymorphisms in Puerto Ricans as well as their role in the warfarin response variability observed in this admixed population.

Study Details

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.3 years ago