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Trial record 89 of 293 for:    warfarin AND anticoagulation

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

Tracking Information
First Submitted Date  ICMJE September 11, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date June 12, 2018
Study Start Date  ICMJE August 2002
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2017)
  • Pharmacokinetic end points: [ Time Frame: 1-4 months ]
  • Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state [ Time Frame: 1-4 months ]
  • Pharmacodynamic. [ Time Frame: 1-4 months ]
  • Maintenance dose of warfarin at steady state. [ Time Frame: 1-4 months ]
  • Time to reach INR > 2. [ Time Frame: 1-4 months ]
  • Time to reach pharmacodynamic steady state. [ Time Frame: 1-4 months ]
  • Time spent at therapeutic INR <3 and >2. [ Time Frame: 1-4 months ]
  • Time spent at INR >3. [ Time Frame: 1-4 months ]
  • Time spent at INR <2. [ Time Frame: 1-4 months ]
  • The incidence of minor and major bleeding episodes. [ Time Frame: 1-4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
  • Pharmacokinetic end points:
  • 1. Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state
  • Pharmacodynamic
  • 1. Maintenance dose of warfarin at steady state
  • 2. Time to reach INR > 2
  • 3. Time to reach pharmacodynamic steady state
  • 4. Time spent at therapeutic INR <3 and >2.
  • 5. Time spent at INR >3
  • 6. Time spent at INR <2
  • 7. The incidence of minor and major bleeding episodes
Change History Complete list of historical versions of study NCT00162435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Genetic Determinants of Warfarin Anticoagulation Effect
Official Title  ICMJE Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Venous Thrombosis
  • Pulmonary Embolism
  • Atrial Fibrillation
Intervention  ICMJE Drug: Warfarin
Study Arms  ICMJE
  • Experimental: Genetic
    Intervention: Drug: Warfarin
  • Experimental: Control
    Intervention: Drug: Warfarin
Publications * 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. Epub 2007 Sep 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2006)
500
Original Enrollment  ICMJE
 (submitted: September 11, 2005)
400
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162435
Other Study ID Numbers  ICMJE yc19553-HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE
  • United States - Israel Binational Science Foundation
  • Israel Science Foundation
  • Ministry of Health, Israel
Investigators  ICMJE
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP