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Multiple Locations, Finland
Completed
NCT Number: NCT04001166
Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland
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.
Completed
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Non-Interventional Study
OtherThis is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.
Primary outcomes
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Incidence of bleeding complications
Time frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of bleeding complications in warfarin-treated individuals
Secondary outcomes
-
Time in Therapeutic Range (TTR)
Time frame: During warfarin treatment and beyond 6 months after the treatment
TTR during first three months in warfarin-treated individuals
-
Time to reach therapeutic range
Time frame: During warfarin treatment and beyond 6 months after the treatment
Time to reach therapeutic range in warfarin-treated individuals
-
Time-weighted mean INR
Time frame: 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
Time frame: 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
Time frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of laboratory visits related to warfarin treatment in warfarin-treated individuals
-
The number of laboratory tests
Time frame: 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
-
Incidence of emergency room (ER) visits
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
VTT Technical Research Centre of Finland
Other
Collaborators
- Auria Biobank
- Finnish Institute for Health and Welfare
- Helsinki Biobank
- Hospital District of Helsinki and Uusimaa
- Hospital District of Southwestern Finland
- Social Insurance Institution, Finland
- THL Biobank
Registry information
Official study title
Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)
Important dates
- Study start
- 2019
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Jun 27, 2019
- Registry last updated
- May 19, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.