Individuals With a Disease of Cardiovascular SystemNCT04001166
Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland
An observational study of Individuals With a Disease of Cardiovascular System, run by VTT Technical Research Centre of Finland at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Individuals With a Disease of Cardiovascular System
- What is being tested?
- Non-interventional study
- How many people
- 7,005 participants
- Where
- 1 siteFinland
- Study dates
- 15 Oct 2019to 28 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
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
About this study
Official title: 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.
Read more
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.
- Being tested
- Non-interventional study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding complications
Incidence of bleeding complications in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Secondary outcomes (10)
Time in Therapeutic Range (TTR)
TTR during first three months in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Time to reach therapeutic range
Time to reach therapeutic range in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Time-weighted mean INR
INR (time-weighed mean) during the first month in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Incidence of outpatients visits
Incidence of outpatient visits caused by bleeding in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Incidence of laboratory visits
Incidence of laboratory visits related to warfarin treatment in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
The number of laboratory tests
The number of performed laboratory tests laboratory tests related to warfarin treatment in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Incidence of emergency room (ER) visits
Incidence of ER visits caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Indicidence of hospital admissions
Hospitalizations caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
The number of hospital inpatient days
The number of inpatient days caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Incidence of medical procedures
Incidence of medical procedures caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals
Measured: During warfarin treatment and beyond 6 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start15 Oct 2019
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Individuals With a Disease of Cardiovascular SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- VTT Technical Research Centre of Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki Biobank, THL Biobank, Auria Biobank, Hospital District of Helsinki and Uusimaa, Hospital District of Southwestern Finland, Finnish Institute for Health and Welfare, Social Insurance Institution, Finland
- Responsible party
- Sponsor
- Investigators
- Jari Ahola, Study director, VTT Technical Research Centre of FinlandMark van Gils, PhD, Principal investigator, VTT Technical Research Centre of Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001166
- Sponsor's protocol ID
- PreMed
- Status last verified
- May 2020
- First submitted
- 28 May 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33727862
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)
- ClinicalTrials.gov ID
- NCT04001166
- Acronym / sponsor ID
- PreMed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,005 participants (actual)
- Lead sponsor
- VTT Technical Research Centre of FinlandUniversity, hospital or other
- Collaborators
- Helsinki Biobank, THL Biobank, Auria Biobank, Hospital District of Helsinki and Uusimaa, Hospital District of Southwestern Finland, Finnish Institute for Health and Welfare, Social Insurance Institution, Finland
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Genotyped for CYP2C9/rs1799853, CYP2C9/rs1057910 and VKORC1/rs9923231
- Diagnosed with at least one of the following:
- Purchased at least one of the following drugs between January 1st 2007 - December 31st 2018:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional studyThis is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician. | Other | – |
Primary outcome
Incidence of bleeding complications
Time frame: During warfarin treatment and beyond 6 months after the treatment
Incidence of bleeding complications in warfarin-treated individuals
10 secondary outcomes
Time in Therapeutic Range (TTR)
Time frame: 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-weighted mean INR
Time frame: 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 laboratory visits
Time frame: 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
Incidence of emergency room (ER) visits
Time frame: 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
The number of hospital inpatient days
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 33727862Vuorinen 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Ahola study director
VTT Technical Research Centre of Finland
Mark van Gils, PhD principal investigator
VTT Technical Research Centre of Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Individuals With a Disease of Cardiovascular System, run by VTT Technical Research Centre of Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bleeding complications (time frame: During warfarin treatment and beyond 6 months after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.