NCT00654823

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 4, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 9, 2008

Status Verified

April 1, 2008

Enrollment Period

2 years

First QC Date

April 4, 2008

Last Update Submit

April 4, 2008

Conditions

Cardiovascular Diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • patients starting warfarin therapy

You may not qualify if:

  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical Pharmacology

Tel Litwinsky, 52621, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ronen Loebstein, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 9, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

April 9, 2008

Record last verified: 2008-04

Locations

IL(1)