An observational study in Individuals With a Disease of Cardiovascular System, sponsored by VTT Technical Research Centre of Finland. Completed at 1 site in Finland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by VTT Technical Research Centre of Finland · Observational
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.
VTT Technical Research Centre of Finland is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adults diagnosed with a disease of cardiovascular system and genotyped for variants in CYP2C9 and VKORC1, and who have used antithrombotic drugs between January 1st 2007 - December 31st 2018.
Diagnosed with at least one of the following:
Purchased at least one of the following drugs between January 1st 2007 - December 31st 2018:
Exclusion Criteria:
This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.
Incidence of bleeding complications
Incidence of bleeding complications in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Time in Therapeutic Range (TTR)
TTR during first three months in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Time to reach therapeutic range
Time to reach therapeutic range in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Time-weighted mean INR
INR (time-weighed mean) during the first month in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of outpatients visits
Incidence of outpatient visits caused by bleeding in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of laboratory visits
Incidence of laboratory visits related to warfarin treatment in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
The number of laboratory tests
The number of performed laboratory tests laboratory tests related to warfarin treatment in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of emergency room (ER) visits
Incidence of ER visits caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Indicidence of hospital admissions
Hospitalizations caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
The number of hospital inpatient days
The number of inpatient days caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of medical procedures
Incidence of medical procedures caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Time frame: During warfarin treatment and beyond 6 months after the treatment
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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VTT Technical Research Centre of Finland