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Genetic Determinants of Warfarin Anticoagulation Effect

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Yosef Caraco, Hadassah Medical Organization
Sponsor:
Collaborators:
United States - Israel Binational Science Foundation
Israel Science Foundation
Ministry of Health, Israel
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00162435
First received: September 11, 2005
Last updated: March 3, 2017
Last verified: March 2017
September 11, 2005
March 3, 2017
August 2002
December 2020   (Final data collection date for primary outcome measure)
  • Pharmacokinetic end points: [ Time Frame: 1-4 months ]
  • Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state [ Time Frame: 1-4 months ]
  • Pharmacodynamic. [ Time Frame: 1-4 months ]
  • Maintenance dose of warfarin at steady state. [ Time Frame: 1-4 months ]
  • Time to reach INR > 2. [ Time Frame: 1-4 months ]
  • Time to reach pharmacodynamic steady state. [ Time Frame: 1-4 months ]
  • Time spent at therapeutic INR <3 and >2. [ Time Frame: 1-4 months ]
  • Time spent at INR >3. [ Time Frame: 1-4 months ]
  • Time spent at INR <2. [ Time Frame: 1-4 months ]
  • The incidence of minor and major bleeding episodes. [ Time Frame: 1-4 months ]
  • Pharmacokinetic end points:
  • 1. Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state
  • Pharmacodynamic
  • 1. Maintenance dose of warfarin at steady state
  • 2. Time to reach INR > 2
  • 3. Time to reach pharmacodynamic steady state
  • 4. Time spent at therapeutic INR <3 and >2.
  • 5. Time spent at INR >3
  • 6. Time spent at INR <2
  • 7. The incidence of minor and major bleeding episodes
Complete list of historical versions of study NCT00162435 on ClinicalTrials.gov Archive Site
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Genetic Determinants of Warfarin Anticoagulation Effect
Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study

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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (masked role unspecified)
Primary Purpose: Treatment
  • Venous Thrombosis
  • Pulmonary Embolism
  • Atrial Fibrillation
Drug: Warfarin
  • Experimental: Genetic
    Intervention: Drug: Warfarin
  • Experimental: Control
    Intervention: Drug: Warfarin
Caraco Y, Blotnick S, Muszkat M. CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: a prospective randomized controlled study. Clin Pharmacol Ther. 2008 Mar;83(3):460-70. Epub 2007 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2020
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il
Israel
 
 
NCT00162435
yc19553-HMO-CTIL
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Yosef Caraco, Hadassah Medical Organization
Hadassah Medical Organization
  • United States - Israel Binational Science Foundation
  • Israel Science Foundation
  • Ministry of Health, Israel
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
Hadassah Medical Organization
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP