NCT04001166

Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland

Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,005 (actual)
• Sponsor: VTT Technical Research Centre of Finland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Individuals With a Disease of Cardiovascular System

Interventions

Type	Name	Description
OTHER	Non-interventional study	This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.

Timeline

• Start date: 2019-10-15
• Primary completion: 2020-04-28
• Completion: 2020-04-28
• First posted: 2019-06-27
• Last updated: 2020-05-19

Locations

1 site across 1 country: Finland