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Genetic Determinants of Warfarin Anticoagulation Effect

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ClinicalTrials.gov Identifier: NCT00162435
Recruitment Status : Recruiting
First Posted : September 13, 2005
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
United States - Israel Binational Science Foundation
Israel Science Foundation
Ministry of Health, Israel
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Venous Thrombosis Pulmonary Embolism Atrial Fibrillation Drug: Warfarin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : August 2002
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Genetic Drug: Warfarin
Experimental: Control Drug: Warfarin


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic end points: [ Time Frame: 1-4 months ]
  2. Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state [ Time Frame: 1-4 months ]
  3. Pharmacodynamic. [ Time Frame: 1-4 months ]
  4. Maintenance dose of warfarin at steady state. [ Time Frame: 1-4 months ]
  5. Time to reach INR > 2. [ Time Frame: 1-4 months ]
  6. Time to reach pharmacodynamic steady state. [ Time Frame: 1-4 months ]
  7. Time spent at therapeutic INR <3 and >2. [ Time Frame: 1-4 months ]
  8. Time spent at INR >3. [ Time Frame: 1-4 months ]
  9. Time spent at INR <2. [ Time Frame: 1-4 months ]
  10. The incidence of minor and major bleeding episodes. [ Time Frame: 1-4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00162435


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

Locations
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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
United States - Israel Binational Science Foundation
Israel Science Foundation
Ministry of Health, Israel
Investigators
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Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00162435     History of Changes
Other Study ID Numbers: yc19553-HMO-CTIL
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Pulmonary Embolism
Atrial Fibrillation
Thrombosis
Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants