Pharmacogenetic Study of Warfarin Dose-Response: a Prospective Trial (PGxWarfarin)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00654823
First received: April 4, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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).


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Comparing Between the Commonly-Used and Pharmacogenetically-Guided Warfarin Administration Protocols

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 500
Study Start Date: June 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • patients starting warfarin therapy

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654823

Locations
Israel
Institute of Clinical Pharmacology Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: Eva Gak, PhD    972-3-530-3946    eva.gak@sheba.health.gov.il   
Principal Investigator: Ronen Loebstein, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ronen Loebstein, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Ronen Loebstein, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00654823     History of Changes
Other Study ID Numbers: SHEBA-XX-XXXX-EG-CTIL
Study First Received: April 4, 2008
Last Updated: April 4, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014