Back to resultsGenetic Determinants of Warfarin Anticoagulation Effect
Primary Purpose
Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Warfarin
Sponsored by
About this trial
This is an interventional treatment trial for Venous Thrombosis
Eligibility 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
Sites / Locations
- Hadassah Medical OrganizationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Genetic
Control
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00162435
First Posted
September 11, 2005
Last Updated
June 11, 2018
Sponsor
Hadassah Medical Organization
Collaborators
United States - Israel Binational Science Foundation, Israel Science Foundation, Ministry of Health, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00162435
Brief Title
Genetic Determinants of Warfarin Anticoagulation Effect
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 Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2002 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
Collaborators
United States - Israel Binational Science Foundation, Israel Science Foundation, Ministry of Health, Israel
4. Oversight
5. Study Description
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:
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.
Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Genetic
Arm Type
Experimental
Arm Title
Control
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Warfarin
Primary Outcome Measure Information:
Title
Pharmacokinetic end points:
Time Frame
1-4 months
Title
Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state
Time Frame
1-4 months
Title
Pharmacodynamic.
Time Frame
1-4 months
Title
Maintenance dose of warfarin at steady state.
Time Frame
1-4 months
Title
Time to reach INR > 2.
Time Frame
1-4 months
Title
Time to reach pharmacodynamic steady state.
Time Frame
1-4 months
Title
Time spent at therapeutic INR <3 and >2.
Time Frame
1-4 months
Title
Time spent at INR >3.
Time Frame
1-4 months
Title
Time spent at INR <2.
Time Frame
1-4 months
Title
The incidence of minor and major bleeding episodes.
Time Frame
1-4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoseph Caraco, MD
Phone
00 972 2 6778584
Email
caraco@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoseph Caraco, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Yoseph Caraco, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17851566
Citation
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. doi: 10.1038/sj.clpt.6100316. Epub 2007 Sep 12.
Results Reference
derived
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Genetic Determinants of Warfarin Anticoagulation Effect
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