Ignite Creation Date:
2024-05-06 @ 9:34 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03015025
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2017-01-02
Brief Title:
Pharmacogenetic Dosage Algorithm for Acenocoumarol
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Organization:
Instituto de Investigación Hospital Universitario La Paz
Study Overview
Official Title:
Creation and Validation of a Pharmacogenetic Dosage Algorithm for Acenocoumarol in Patients With Venous Thromboembolic Disease Atrial Fibrillation andor Mechanical Valvular Heart Prosthesis
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
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 use of coumarins has been a challenge for doctors because of its narrow therapeutic range and they show great inter and intra-individual variability in the dose necessary to achieve an international normalized ratio INR within the therapeutic range Among the factors influencing the interindividual variability in the dose required include age weight Vitamin K in the diet comorbidity as well as drug interactions and in recent years has also seen the importance of pharmacogenetic factors
Detailed Description:
Demographic and clinical factors contribute approximately 20 to the total variability of dose requirements In recent years it has highlighted the close relationship between the dose requirements of coumarin drugs and certain polymorphisms of genes involved in pharmacokinetics and pharmacodynamics of these drugs The use of dosing algorithms that include pharmacogenetic information may help in the dose selection improving efficacy and reducing adverse events Studies have shown the relationship between genotype variants of CYP2C9 and VKORC1 CYP4F2 and apolipoprotein E ApoE which together with the demographic and clinical variants can explain between 50-60 of the variability in the response to these drugs
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