The Association of Warfarin Dosage and Plasma Enantiomer Concentration With the Gene Polymorphisms of CYP and VKOR

NCT ID: NCT00247702

Last Updated: 2005-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-06-30

Brief Summary

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Oral warfarin anticogulation for the prevention and treatment of patients with venous thromboembolism is one of the most used therapies in clinical practice. Patients require different dosage to achieve the target therapeutic anticoagulation. Optimal dosage and bleeding complication are two most clinical concerns. Besides of multiple individual factors (e.g. age, dietary intake, vitamin supplement, drug compliance etc.), some genetic factors may determine the drug requirement and safety.

The cytochrome P450 CYP2C9 is a liver enzyme required for the oxidative metabolism of warfarin. The vitamin K epoxide redutase (VKOR) is a liver enzyme associated with the reuse of the oxidative hydroquinone form of vitamin K. The VKOR enzyme is the target of warfarin. Recent studies revealed both genes may determine the pharmacodynamic of warfarin anticogualation. To date, there are more than thirteen identified polymorphism at CYP2C9 gene. Majority of those variant polymorphisms may decrease the warfarin requirement. The VKOR complex subunit 1 (VKORC1) is a newly identified gene. Some polymorphisms also were reported.

As we know, the Chinese patients need a lower dosage of warfarin in comparison with the Caucasian patients. We are interested in finding the genetic causes of Taiwneses Chinese patients. In our study we will first identify the polymorphism patterns of these two genes in normal population. Then, we will try to find the association between these polymorphism and patient warfarin requirement. Our pharmacogenetics study will be valuable for prevention of bleeding complication of warfarin treatment in Chinese population.

Detailed Description

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Conditions

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Deep Venous Thromboembolism

Keywords

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CYP2C9 VKORC1 polymorphism warfarin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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warfarin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Use warfarin therapy for at least two months before study
* Stable INR value during recent three months

Exclusion Criteria

* higher age(\>80 y/o)
* liver and renal dysfunction
* alcohol abuse
* BMI\<18kg/m2
* coadministered medicine that can affect pharmacokinetics or pharmacodynamics of warfarin
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Tasy Wei, Doctor

Role: STUDY_CHAIR

National Taiwan Univerisity Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tsay Wei, Doctor

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Tsay Wei, Doctor

Role: primary

Other Identifiers

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940609

Identifier Type: -

Identifier Source: org_study_id