VKORC1 and CYP2C9 Gene Polymorphisms and Warfarin Management
Evaluation of VKORC1 and Cytochrome P450 CYP2C9 Gene Polymorphisms and Management of Warfarin Dose Using Pharmacogenetic Data
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 3, 2009
September 1, 2009
3 years
September 2, 2009
September 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Warfarin related complications including bleeding and thromboembolism
6 months
Secondary Outcomes (1)
Maximal time in international normalized ratio (INR) therapeutic range and deviation from target INR levels
6 months
Interventions
Dosage
Eligibility Criteria
Patients who require warfarin for at least 6 months under care of cardiovascular surgery, cardiology and pulmonary disease.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Medical Faculty, Department of Cardiovascular Surgery and Pulmonary Disease
Ankara, 06340, Turkey (Türkiye)
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nejat Akar, Prof
Ankara University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2012
Study Completion
December 1, 2012
Last Updated
September 3, 2009
Record last verified: 2009-09