Pharmacogenetics of Warfarin in Puerto Ricans.
NCT01318057 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 350
Last updated 2015-01-21
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.
Conditions
- Atrial Fibrillation
- Deep Vein Thrombosis
- Cardiac Valvular Insufficiency
- Antiphospholipid Syndrome
- Coagulopathy
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Hartford Hospital
collaborator OTHER -
VA Caribbean Healthcare System
collaborator FED -
University of Puerto Rico
lead OTHER
Principal Investigators
-
Giselle T Rivera-Miranda, PharmD · VACHS at San Juan
-
Jorge Duconge, PhD · University of Puerto Rico
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-28
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- Puerto Rico
Study Locations
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