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

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

OTHER

Non-interventional study

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

Sponsors & Collaborators

• Helsinki Biobank

  collaborator UNKNOWN

• THL Biobank

  collaborator UNKNOWN

• Auria Biobank

  collaborator UNKNOWN

• Hospital District of Helsinki and Uusimaa

  collaborator OTHER

• Hospital District of Southwestern Finland

  collaborator OTHER

• Finnish Institute for Health and Welfare

  collaborator OTHER_GOV

• Social Insurance Institution, Finland

  collaborator OTHER

• VTT Technical Research Centre of Finland

  lead OTHER

Principal Investigators

• Jari Ahola · VTT Technical Research Centre of Finland

• Mark van Gils, PhD · VTT Technical Research Centre of Finland

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-15

Primary Completion

2020-04-28

Completion

2020-04-28

Countries

• Finland