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

May 18, 2020 updated by: VTT Technical Research Centre of Finland

Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7005

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bleeding complications
Time Frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of bleeding complications in warfarin-treated individuals
During warfarin treatment and beyond 6 months after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment
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
During warfarin treatment and beyond 6 months after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VTT Technical Research Centre of Finland

Collaborators

Social Insurance Institution, Finland
Finnish Institute for Health and Welfare
Hospital District of Helsinki and Uusimaa
Hospital District of Southwestern Finland
Helsinki Biobank
THL Biobank
Auria Biobank

Investigators

  • Study Director: Jari Ahola, VTT Technical Research Centre of Finland
  • Principal Investigator: Mark van Gils, PhD, VTT Technical Research Centre of Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

April 28, 2020

Study Completion (Actual)

April 28, 2020

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

June 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PreMed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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