Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT04001166
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2019-05-28
Brief Title:
Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland
Sponsor:
VTT Technical Research Centre of Finland
Organization:
VTT Technical Research Centre of Finland
Study Overview
Official Title:
Pharmacogenomics of Antithrombotic Drugs PreMed PGx Study
Status:
COMPLETED
Status Verified Date:
2020-05
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:
This is a retrospective cohort study linking data from Finnish Biobanks Helsinki Biobank Auria Biobank and THL Biobank laboratory databases and national registries of Social Insurance Institution of Finland Kela and the National Institute of Health and Welfare THL to investigate pharmacogenomics of antithrombotic drugs in the Finnish population The purpose of the study is to assess clinical and economic aspects of using genomic data in the context of antithrombotic drug therapy
Based on earlier research data regarding variant alleles in CYP2C9 and VKORC1 will be used in the primary analyses Individuals with and without specific variant alleles are compared in respect to their clinical response to warfarin therapy Warfarin-treated individuals are also analysed in relation to other clinical outcomes and a wide range of healthcare encounters
The explorative part of the study will employ data-driven classification methods to explore genotype-phenotype associations for a larger group of antithrombotic drugs including direct oral anticoagulants clopidogrel and heparins and possible interactions with other drugs In this part 26 gene variants identified in literature will be used
The retrospective follow-up time for the study participants is from January 2007 to December 2018 or 2 years prior the first anticoagulant drug is purchased until 6 months after the last purchase
Based on earlier research data regarding variant alleles in CYP2C9 and VKORC1 will be used in the primary analyses Individuals with and without specific variant alleles are compared in respect to their clinical response to warfarin therapy Warfarin-treated individuals are also analysed in relation to other clinical outcomes and a wide range of healthcare encounters
The explorative part of the study will employ data-driven classification methods to explore genotype-phenotype associations for a larger group of antithrombotic drugs including direct oral anticoagulants clopidogrel and heparins and possible interactions with other drugs In this part 26 gene variants identified in literature will be used
The retrospective follow-up time for the study participants is from January 2007 to December 2018 or 2 years prior the first anticoagulant drug is purchased until 6 months after the last purchase
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None