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
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.
|Condition or disease||Intervention/treatment||Phase|
|Venous Thrombosis Pulmonary Embolism Atrial Fibrillation||Drug: Warfarin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2002|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162435
|Contact: Yoseph Caraco, MD||00 972 2 firstname.lastname@example.org|
|Principal Investigator:||Yoseph Caraco, MD||Hadassah Medical Organization|