- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00162435
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:
- 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yoseph Caraco, MD
- Phone Number: 00 972 2 6778584
- Email: caraco@hadassah.org.il
Study Locations
-
-
-
Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
-
Principal Investigator:
- Yoseph Caraco, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
|
|
Experimental: Genetic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic end points:
Time Frame: 1-4 months
|
1-4 months
|
Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state
Time Frame: 1-4 months
|
1-4 months
|
Pharmacodynamic.
Time Frame: 1-4 months
|
1-4 months
|
Maintenance dose of warfarin at steady state.
Time Frame: 1-4 months
|
1-4 months
|
Time to reach INR > 2.
Time Frame: 1-4 months
|
1-4 months
|
Time to reach pharmacodynamic steady state.
Time Frame: 1-4 months
|
1-4 months
|
Time spent at therapeutic INR <3 and >2.
Time Frame: 1-4 months
|
1-4 months
|
Time spent at INR >3.
Time Frame: 1-4 months
|
1-4 months
|
Time spent at INR <2.
Time Frame: 1-4 months
|
1-4 months
|
The incidence of minor and major bleeding episodes.
Time Frame: 1-4 months
|
1-4 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yoseph Caraco, MD, Hadassah Medical Organization
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yc19553-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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