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Evaluation of VKORC1 and Cytochrome P450 CYP2C9 Gene Polymorphisms and Management of Warfarin Dose Using Pharmacogenetic Data

This study is currently Recruiting

September 2009 By Ankara University

First Recieved on September 2, 2009

Last Updated on September 2, 2009

Sponsor: Ankara University
Collaborators:
Information provided by: Ankara University
Identifier: NCT00970892

Purpose

The investigators aimed to use pharmacogenetic information in clinical practise which may lead to rapid, efficient, and safe warfarin dosing in this observational prospective study. In this context, the investigators plan to develop an algorithm for estimating the appropriate warfarin dose that is based on both clinical and genetic data from the Turkish study population. This study is unique not only investigating clinical factors, demographic variables, CYP2C9, and VKORC1 gene variations which contribute to the variability among patients in dose requirements for warfarin but also including thrombogenic single nucleotide polymorphisms (SNP) in the same patient population. Thus, warfarin would be a good example by being the first cardiovascular drug for pharmacogenetic guided "personalized medicine" applications.

Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: Patients who require warfarin for at least 6 months with the indications listed below: - Permanent Atrial Fibrillation/Flutter - Left atrial or ventricular thrombus - Deep Vein Thrombosis - Pulmonary Embolism - Heart Valve Replacement (Mechanical or Biological With AF) - Cardiomyopathy (Ischemic or Dilated) - Peripheral Vascular Disease Exclusion Criteria: - History of GI bleeding or peptic ulcer disease - Significant liver disease, active hepatitis or chronic HBV/HCV infection - Uncontrolled hypertension - Chronic diarrhea or malabsorption syndrome - Viral or bacterial infection prior to enrollment - Active or previous infective endocarditis - Hospital stay > 30 days as a result of septicemia, mediastinitis or pneumonia - Cardiac cachexia - Morbid obesity - Expected pregnancy, pregnancy or lactation - Psychiatric disease - Malignancy with Life expectancy less than 1 year

Investigators

  • Investigator: Nejat Akar, Prof - Principal Investigator - Ankara University

Locations

  • Ankara University Medical Faculty, Department of Cardiovascular Surgery and Pulmonary Disease

    Ankara, 06340 Turkey

Conditions related to this trial:

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