NCT00162435

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. 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 12, 2018

Status Verified

March 1, 2018

Enrollment Period

18.3 years

First QC Date

September 11, 2005

Last Update Submit

June 11, 2018

Conditions

Venous ThrombosisPulmonary EmbolismAtrial Fibrillation

Outcome Measures

Primary Outcomes (10)

  • Pharmacokinetic end points:

    1-4 months

  • Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state

    1-4 months

  • Pharmacodynamic.

    1-4 months

  • Maintenance dose of warfarin at steady state.

    1-4 months

  • Time to reach INR > 2.

    1-4 months

  • Time to reach pharmacodynamic steady state.

    1-4 months

  • Time spent at therapeutic INR <3 and >2.

    1-4 months

  • Time spent at INR >3.

    1-4 months

  • Time spent at INR <2.

    1-4 months

  • The incidence of minor and major bleeding episodes.

    1-4 months

Study Arms (2)

Genetic

EXPERIMENTAL
Drug: Warfarin

Control

EXPERIMENTAL
Drug: Warfarin

Interventions

WarfarinDRUG
ControlGenetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in whom warfarin is about to be initiated
  • Desired therapeutic range \>2 and \<3

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 17851566DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismAtrial Fibrillation

Interventions

Warfarin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Yoseph Caraco, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoseph Caraco, MD

CONTACT

00 972 2 6778584caraco@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 13, 2005

Study Start

August 1, 2002

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 12, 2018

Record last verified: 2018-03

Locations

IL(1)