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Genetic Determinants of Warfarin Anticoagulation Effect

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Israel Binational Science Foundation, United States
Israel Science Foundation
Ministry of Health, Israel
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162435
First received: September 11, 2005
Last updated: October 28, 2008
Last verified: October 2008
History of Changes
  Purpose

The response to warfarin varies greatly among individuals. Some of this variability can be ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1, factor VII) have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9.The present study has several segments:

  1. Evaluation of the relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study is a confirmation of previous data in our own population.
  2. Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.
  3. Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9, VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects.

Condition Intervention
Venous Thrombosis
Pulmonary Embolism
Atrial Fibrillation
 Drug: Warfarin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Pharmacokinetic end points:
  • Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state
  • Pharmacodynamic.
  • Maintenance dose of warfarin at steady state.
  • Time to reach INR > 2.
  • Time to reach pharmacodynamic steady state.
  • Time spent at therapeutic INR <3 and >2.
  • Time spent at INR >3.
  • Time spent at INR <2.
  • The incidence of minor and major bleeding episodes.

Estimated Enrollment: 500
Study Start Date: August 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in whom warfarin is about to be initiated
  • Desired therapeutic range >2 and <3

Exclusion Criteria:

  • Refusal to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162435

Contacts
Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Yoseph Caraco, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Israel Binational Science Foundation, United States
Israel Science Foundation
Ministry of Health, Israel
Investigators
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
  More Information

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00162435     History of Changes
Other Study ID Numbers: yc19553-HMO-CTIL
Study First Received: September 11, 2005
Last Updated: October 28, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013