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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Individuals With a Disease of Cardiovascular System | Other: Non-interventional study |
| Study Type : | Observational |
| Actual Enrollment : | 7005 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study) |
| Actual Study Start Date : | October 15, 2019 |
| Actual Primary Completion Date : | April 28, 2020 |
| Actual Study Completion Date : | April 28, 2020 |
- Incidence of bleeding complications [ Time Frame: During warfarin treatment and beyond 6 months after the treatment ]Incidence of bleeding complications in warfarin-treated individuals
- 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
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | May 28, 2019 | ||||||
| First Posted Date | June 27, 2019 | ||||||
| Last Update Posted Date | May 19, 2020 | ||||||
| Actual Study Start Date | October 15, 2019 | ||||||
| Actual Primary Completion Date | April 28, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
Incidence of bleeding complications [ Time Frame: During warfarin treatment and beyond 6 months after the treatment ] Incidence of bleeding complications in warfarin-treated individuals
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| Original Primary Outcome Measures |
Bleeding complications [ Time Frame: During warfarin treatment and beyond 6 months after the treatment ] Incidence of bleeding complications in warfarin-treated individuals
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| Change History | |||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland | ||||||
| Official Title | Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study) | ||||||
| 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. |
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| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| 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. | ||||||
| Condition | Individuals With a Disease of Cardiovascular System | ||||||
| Intervention | Other: Non-interventional study
This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Vuorinen AL, Lehto M, Niemi M, Harno K, Pajula J, van Gils M, Lähteenmäki 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. | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
7005 | ||||||
| Original Estimated Enrollment |
2678 | ||||||
| Actual Study Completion Date | April 28, 2020 | ||||||
| Actual Primary Completion Date | April 28, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Finland | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04001166 | ||||||
| Other Study ID Numbers | PreMed | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | VTT Technical Research Centre of Finland | ||||||
| Study Sponsor | VTT Technical Research Centre of Finland | ||||||
| Collaborators |
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| Investigators |
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| PRS Account | VTT Technical Research Centre of Finland | ||||||
| Verification Date | May 2020 | ||||||
