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

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ClinicalTrials.gov Identifier: NCT04001166
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Helsinki Biobank
THL Biobank
Auria Biobank
Hospital District of Helsinki and Uusimaa
Hospital District of Southwestern Finland
National Institute for Health and Welfare, Finland
Social Insurance Institution, Finland
Information provided by (Responsible Party):
VTT Technical Research Centre of Finland

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.


Condition or disease Intervention/treatment
Individuals With a Disease of Cardiovascular System Other: Non-interventional study

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Study Type : Observational
Estimated Enrollment : 2678 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners


Intervention Details:
  • Other: Non-interventional study
    This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001166


Locations
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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.
Multiple Locations, Finland
Sponsors and Collaborators
VTT Technical Research Centre of Finland
Helsinki Biobank
THL Biobank
Auria Biobank
Hospital District of Helsinki and Uusimaa
Hospital District of Southwestern Finland
National Institute for Health and Welfare, Finland
Social Insurance Institution, Finland
Investigators
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Study Director: Jari Ahola VTT Technical Research Centre of Finland
Principal Investigator: Mark van Gils, PhD VTT Technical Research Centre of Finland

Additional Information:
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Responsible Party: VTT Technical Research Centre of Finland
ClinicalTrials.gov Identifier: NCT04001166     History of Changes
Other Study ID Numbers: PreMed
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No