Ignite Creation Date:
2024-05-05 @ 9:51 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00970892
Status:
UNKNOWN
Last Update Posted:
2009-09-03
First Post:
2009-09-02
Brief Title:
VKORC1 and CYP2C9 Gene Polymorphisms and Warfarin Management
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
Evaluation of VKORC1 and Cytochrome P450 CYP2C9 Gene Polymorphisms and Management of Warfarin Dose Using Pharmacogenetic Data
Status:
UNKNOWN
Status Verified Date:
2009-09
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 investigators aimed to use pharmacogenetic information in clinical practise which may lead to rapid efficient and safe warfarin dosing in this observational prospective study In this context the investigators plan to develop an algorithm for estimating the appropriate warfarin dose that is based on both clinical and genetic data from the Turkish study population This study is unique not only investigating clinical factors demographic variables CYP2C9 and VKORC1 gene variations which contribute to the variability among patients in dose requirements for warfarin but also including thrombogenic single nucleotide polymorphisms SNP in the same patient population Thus warfarin would be a good example by being the first cardiovascular drug for pharmacogenetic guided personalized medicine applications
Detailed Description:
Long-term anticoagulation therapy with warfarin is recommended for patients with atrial fibrillationflutter AF left atrial thrombus deep vein thrombosis DVT pulmonary thromboembolism PE mechanical heart valve replacement cardiomyopathy and ischemic stroke Warfarin a coumarin derivative produces an anticoagulant effect by interfering with the vitamin K 23 epoxide reductase VKOR enzyme and γ-carboxylation of vitamin K-dependent clotting factors such as II VII IX and X However management of warfarin therapy is complicated with interindividual differences in drug response delayed onset of action difficulty with reversal and a narrow therapeutic window leading to increased risk of life-threatening hemorrhagic adverse events or thromboembolism Furthermore in order to determine safe and effective loading dose during the early phase of therapy and maintenance doses require frequent laboratory monitoring and adjustments to compensate for changes in patients age body size vitamin K intake through diet disease state comorbidities concomitant use of other medications and patient-specific genetic factors
Poor anticoagulant control may cause fatal complications such as thromboembolism with undertreatment or bleeding with excessive anticoagulation Indeed the risk of major bleeding in patients on warfarin is between 1 and 5 per year Identifying the optimal therapeutic range and managing the dose of therapy to achieve the maximal time in therapeutic range are two of the most important determinants of therapeutic effectiveness and of reducing hemorrhagic risk Currently there have been substantial efforts to improve the safety of warfarin anticoagulation therapy Recent warfarin pharmacogenetic studies have largely focused on two candidate genes CYP2C9 responsible for warfarin metabolism and VKORC1 which encodes vitamin K epoxide reductase the site of warfarin action Current evidence is clear that polymorphisms in either CYP2C9 or VKORC1 affect warfarin sensitivity
We aimed to use pharmacogenetic information in clinical practise which may lead to rapid efficient and safe warfarin dosing in this observational prospective study In this context we plan to develop an algorithm for estimating the appropriate warfarin dose that is based on both clinical and genetic data from the Turkish study population This study is unique not only investigating clinical factors demographic variables CYP2C9 and VKORC1 gene variations which contribute to the variability among patients in dose requirements for warfarin but also including thrombogenic single nucleotide polymorphisms SNP in the same patient population Thus warfarin would be a good example by being the first cardiovascular drug for pharmacogenetic guided personalized medicine applications
Poor anticoagulant control may cause fatal complications such as thromboembolism with undertreatment or bleeding with excessive anticoagulation Indeed the risk of major bleeding in patients on warfarin is between 1 and 5 per year Identifying the optimal therapeutic range and managing the dose of therapy to achieve the maximal time in therapeutic range are two of the most important determinants of therapeutic effectiveness and of reducing hemorrhagic risk Currently there have been substantial efforts to improve the safety of warfarin anticoagulation therapy Recent warfarin pharmacogenetic studies have largely focused on two candidate genes CYP2C9 responsible for warfarin metabolism and VKORC1 which encodes vitamin K epoxide reductase the site of warfarin action Current evidence is clear that polymorphisms in either CYP2C9 or VKORC1 affect warfarin sensitivity
We aimed to use pharmacogenetic information in clinical practise which may lead to rapid efficient and safe warfarin dosing in this observational prospective study In this context we plan to develop an algorithm for estimating the appropriate warfarin dose that is based on both clinical and genetic data from the Turkish study population This study is unique not only investigating clinical factors demographic variables CYP2C9 and VKORC1 gene variations which contribute to the variability among patients in dose requirements for warfarin but also including thrombogenic single nucleotide polymorphisms SNP in the same patient population Thus warfarin would be a good example by being the first cardiovascular drug for pharmacogenetic guided personalized medicine applications
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