Genetic Determinants of Warfarin Anticoagulation Effect

NCT ID: NCT00162435

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thrombosis Pulmonary Embolism Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Genetic

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Control

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Interventions

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Warfarin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States - Israel Binational Science Foundation

OTHER

Sponsor Role collaborator

Israel Science Foundation

OTHER

Sponsor Role collaborator

Ministry of Health, Israel

OTHER_GOV

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoseph Caraco, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yoseph Caraco, MD

Role: CONTACT

00 972 2 6778584

Facility Contacts

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Arik Tzukert, DMD

Role: primary

00 972 2 6776095

Hadas Lemberg, PhD

Role: backup

00 972 2 6777572

References

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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.

Reference Type DERIVED
PMID: 17851566 (View on PubMed)

Other Identifiers

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yc19553-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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