Individuals With a Disease of Cardiovascular System
Conditions
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.
Interventions
OTHERNon-interventional study
This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.
Sponsors
Helsinki Biobank
THL Biobank
Auria Biobank
Hospital District of Helsinki and Uusimaa
Hospital District of Southwestern Finland
Finnish Institute for Health and Welfare
Social Insurance Institution, Finland
VTT Technical Research Centre of Finland
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Genotyped for CYP2C9/rs1799853, CYP2C9/rs1057910 and VKORC1/rs9923231 * Diagnosed with at least one of the following: * Atrial Fibrillation and Flutter (I48) * Ischemic Heart Disease (I20-I25) * Cerebrovascular disease (I63,I65,I66, 167.2, I69.3-I69.8) * Atherosclerosis (I70) * Pulmonary embolism (I26) * Phlebitis and thrombophlebitis (I80) * Portal vein thrombosis (I81) * Other venous embolism and thrombosis (I82) * Purchased at least one of the following drugs between January 1st 2007 - December 31st 2018: * Anticoagulants: Warfarin, Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Heparin, Enoxaparin, Dalteparin * Antiplatelets: Clopidogrel, Ticagrelor, Acetylsalicylic acid
Exclusion criteria
* Permanent residence in Finland less than 12 months during the follow-up period * Purchase of any of the antithrombotic drugs listed above between January 1st 2005 - December 31st 2006
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bleeding complications | During warfarin treatment and beyond 6 months after the treatment | Incidence of bleeding complications in warfarin-treated individuals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach therapeutic range | During warfarin treatment and beyond 6 months after the treatment | Time to reach therapeutic range in warfarin-treated individuals |
| Time-weighted mean INR | During warfarin treatment and beyond 6 months after the treatment | INR (time-weighed mean) during the first month in warfarin-treated individuals |
| Incidence of outpatients visits | During warfarin treatment and beyond 6 months after the treatment | Incidence of outpatient visits caused by bleeding in warfarin-treated individuals |
| Incidence of laboratory visits | During warfarin treatment and beyond 6 months after the treatment | Incidence of laboratory visits related to warfarin treatment in warfarin-treated individuals |
| Time in Therapeutic Range (TTR) | During warfarin treatment and beyond 6 months after the treatment | TTR during first three months in warfarin-treated individuals |
| Incidence of emergency room (ER) visits | During warfarin treatment and beyond 6 months after the treatment | Incidence of ER visits caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals |
| Indicidence of hospital admissions | During warfarin treatment and beyond 6 months after the treatment | Hospitalizations caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals |
| The number of hospital inpatient days | During warfarin treatment and beyond 6 months after the treatment | The number of inpatient days caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals |
| Incidence of medical procedures | During warfarin treatment and beyond 6 months after the treatment | Incidence of medical procedures caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals |
| The number of laboratory tests | During warfarin treatment and beyond 6 months after the treatment | The number of performed laboratory tests laboratory tests related to warfarin treatment in warfarin-treated individuals |
Countries
Finland
Outcome results
None listed