MedTrace Logo

Pharmacogenetic Study of Warfarin Dose-Response: a Prospective Trial

NCT00654823 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2008-04-09

No results posted yet for this study

Summary

We propose to develop a personalized pharmacogenetic approach including the major genetic markers of warfarin (coumadin) dosing and patients' age and weight. The known genetic determinants include several functional and common polymorphisms in CYP2C9 and VKORC1 genes, which explain the low-end of warfarin dosing range and mostly occur in patients of Caucasian and Chinese origins. We identified a new VKORC1 polymorphism that is specifically indicative of the high dose requirements and is dominant over the dose-reducing effect of the known CYP2C9 and VKORC1 markers. This marker is significantly over-represented in Jews of Ethiopian origin, but is also common in Ashkenazis, it is also linked to the VKORC1 genetic markers characteristic of the Afro-American population (published in Blood 2007, 109:2477-80). This information prompts the development of a more inclusive and universal diagnostic approach to the individualized warfarin therapy.

The present study aims at evaluation of our novel pharmacogenetic model for predicting warfarin (coumadin) dose response on the basis of patient's genetic markers of warfarin sensitivity and resistance, and other patient specific factors. To this end, we proposes to re-evaluate our previously developed pharmacogenetic model in stabilized warfarin treated patients (N=200) and then to implement it in a prospective study of patients new on warfarin as compared to the "traditionally" treated patients (N=500).

Conditions

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ronen Loebstein, MD · Sheba Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-06-30
Completion
2011-06-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00654823 on ClinicalTrials.gov