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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00654823
Recruitment Status : Unknown
Verified April 2008 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2008
Last Update Posted : April 9, 2008
Information provided by:
Sheba Medical Center

Brief 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).

Condition or disease
Cardiovascular Diseases

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Comparing Between the Commonly-Used and Pharmacogenetically-Guided Warfarin Administration Protocols
Study Start Date : June 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Biospecimen Retention:   Samples With DNA
Whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample

Inclusion Criteria:

  • patients starting warfarin therapy

Exclusion Criteria:

  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00654823

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Institute of Clinical Pharmacology
Tel Hashomer, Israel, 52621
Contact: Eva Gak, PhD    972-3-530-3946   
Principal Investigator: Ronen Loebstein, MD         
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Ronen Loebstein, MD Sheba Medical Center
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Responsible Party: Dr. Ronen Loebstein, Sheba Medical Center Identifier: NCT00654823    
Other Study ID Numbers: SHEBA-XX-XXXX-EG-CTIL
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: April 9, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Cardiovascular Diseases