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

NCT04001166 | Completed

• 1 other identifier: PreMed
• Study Type: observational
• Target: 7,005
• Locations: 1 country
• Sites: 1

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.

Conditions

Individuals With a Disease of Cardiovascular System

Outcome Measures

Primary Outcomes (1)

• Incidence of bleeding complications

  Incidence of bleeding complications in warfarin-treated individuals

  During warfarin treatment and beyond 6 months after the treatment

Secondary Outcomes (10)

• Time in Therapeutic Range (TTR)

  During warfarin treatment and beyond 6 months after the treatment

• Time to reach therapeutic range

  During warfarin treatment and beyond 6 months after the treatment

• Time-weighted mean INR

  During warfarin treatment and beyond 6 months after the treatment

• Incidence of outpatients visits

  During warfarin treatment and beyond 6 months after the treatment

• Incidence of laboratory visits

  During warfarin treatment and beyond 6 months after the treatment

Interventions

Non-interventional study OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VTT Technical Research Centre of Finland: lead
• Helsinki Biobank: collaborator
• THL Biobank: collaborator
• Auria Biobank: collaborator
• Hospital District of Helsinki and Uusimaa: collaborator
• Hospital District of Southwestern Finland: collaborator
• Finnish Institute for Health and Welfare: collaborator
• Social Insurance Institution, Finland: collaborator

Study Sites (1)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Multiple Locations, Finland

Location

Related Publications (1)

• Vuorinen AL, Lehto M, Niemi M, Harno K, Pajula J, van Gils M, Lahteenmaki J. Pharmacogenetics of Anticoagulation and Clinical Events in Warfarin-Treated Patients: A Register-Based Cohort Study with Biobank Data and National Health Registries in Finland. Clin Epidemiol. 2021 Mar 8;13:183-195. doi: 10.2147/CLEP.S289031. eCollection 2021.

  PMID: 33727862 DERIVED

Related Links

• Related Info

Study Officials

• Jari Ahola

  VTT Technical Research Centre of Finland

  STUDY DIRECTOR

• Mark van Gils, PhD

  VTT Technical Research Centre of Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 27, 2019
• Study Start: October 15, 2019
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

FI (1)