Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162435
Status:
UNKNOWN
Last Update Posted:
2018-06-12
First Post:
2005-09-11
Brief Title:
Genetic Determinants of Warfarin Anticoagulation Effect
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie VKORC1 factor VII have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9The 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 individuals combined CYP2C9 VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects
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 individuals combined CYP2C9 VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None