VKORC1 and CYP2C9 Gene Polymorphisms and Warfarin Management

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ankara University
• Treatments: Warfarin

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