Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
Study NCT ID:
NCT04001166
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2019-05-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7005}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of bleeding complications', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'Incidence of bleeding complications in warfarin-treated individuals'}], 'secondaryOutcomes': [{'measure': 'Time in Therapeutic Range (TTR)', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'TTR during first three months in warfarin-treated individuals'}, {'measure': 'Time to reach therapeutic range', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'Time to reach therapeutic range in warfarin-treated individuals'}, {'measure': 'Time-weighted mean INR', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'INR (time-weighed mean) during the first month in warfarin-treated individuals'}, {'measure': 'Incidence of outpatients visits', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'Incidence of outpatient visits caused by bleeding in warfarin-treated individuals'}, {'measure': 'Incidence of laboratory visits', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'Incidence of laboratory visits related to warfarin treatment in warfarin-treated individuals'}, {'measure': 'The number of laboratory tests', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'The number of performed laboratory tests laboratory tests related to warfarin treatment in warfarin-treated individuals'}, {'measure': 'Incidence of emergency room (ER) visits', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'Incidence of ER visits caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals'}, {'measure': 'Indicidence of hospital admissions', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'Hospitalizations caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals'}, {'measure': 'The number of hospital inpatient days', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'The number of inpatient days caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals'}, {'measure': 'Incidence of medical procedures', 'timeFrame': 'During warfarin treatment and beyond 6 months after the treatment', 'description': 'Incidence of medical procedures caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Individuals With a Disease of Cardiovascular System']}, 'referencesModule': {'references': [{'pmid': '33727862', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.vtt.fi/premed', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBased 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genotyped for CYP2C9/rs1799853, CYP2C9/rs1057910 and VKORC1/rs9923231\n* Diagnosed with at least one of the following:\n\n * Atrial Fibrillation and Flutter (I48)\n * Ischemic Heart Disease (I20-I25)\n * Cerebrovascular disease (I63,I65,I66, 167.2, I69.3-I69.8)\n * Atherosclerosis (I70)\n * Pulmonary embolism (I26)\n * Phlebitis and thrombophlebitis (I80)\n * Portal vein thrombosis (I81)\n * Other venous embolism and thrombosis (I82)\n* Purchased at least one of the following drugs between January 1st 2007 - December 31st 2018:\n\n * Anticoagulants: Warfarin, Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Heparin, Enoxaparin, Dalteparin\n * Antiplatelets: Clopidogrel, Ticagrelor, Acetylsalicylic acid\n\nExclusion Criteria:\n\n* Permanent residence in Finland less than 12 months during the follow-up period\n* Purchase of any of the antithrombotic drugs listed above between January 1st 2005 - December 31st 2006'}, 'identificationModule': {'nctId': 'NCT04001166', 'briefTitle': 'Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland', 'organization': {'class': 'OTHER', 'fullName': 'VTT Technical Research Centre of Finland'}, 'officialTitle': 'Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)', 'orgStudyIdInfo': {'id': 'PreMed'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-interventional study', 'type': 'OTHER', 'description': "This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Finland', 'facility': 'To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.'}], 'overallOfficials': [{'name': 'Jari Ahola', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VTT Technical Research Centre of Finland'}, {'name': 'Mark van Gils, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VTT Technical Research Centre of Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VTT Technical Research Centre of Finland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki Biobank', 'class': 'UNKNOWN'}, {'name': 'THL Biobank', 'class': 'UNKNOWN'}, {'name': 'Auria Biobank', 'class': 'UNKNOWN'}, {'name': 'Hospital District of Helsinki and Uusimaa', 'class': 'OTHER'}, {'name': 'Hospital District of Southwestern Finland', 'class': 'OTHER'}, {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, {'name': 'Social Insurance Institution, Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}