Individuals With a Disease of Cardiovascular System Clinical Trial
Official title:
Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)
| NCT number | NCT04001166 |
| Other study ID # | PreMed |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 15, 2019 |
| Est. completion date | April 28, 2020 |
| Verified date | May 2020 |
| Source | VTT Technical Research Centre of Finland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 7005 |
| Est. completion date | April 28, 2020 |
| Est. primary completion date | April 28, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| VTT Technical Research Centre of Finland | Auria Biobank, Helsinki Biobank, Hospital District of Helsinki and Uusimaa, Hospital District of Southwestern Finland, National Institute for Health and Welfare, Finland, Social Insurance Institution, Finland, THL Biobank |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of bleeding complications | Incidence of bleeding complications in warfarin-treated individuals | During warfarin treatment and beyond 6 months after the treatment | |
| Secondary | Time in Therapeutic Range (TTR) | TTR during first three months in warfarin-treated individuals | During warfarin treatment and beyond 6 months after the treatment | |
| Secondary | Time to reach therapeutic range | Time to reach therapeutic range in warfarin-treated individuals | During warfarin treatment and beyond 6 months after the treatment | |
| Secondary | Time-weighted mean INR | INR (time-weighed mean) during the first month in warfarin-treated individuals | During warfarin treatment and beyond 6 months after the treatment | |
| Secondary | Incidence of outpatients visits | Incidence of outpatient visits caused by bleeding in warfarin-treated individuals | During warfarin treatment and beyond 6 months after the treatment | |
| Secondary | Incidence of laboratory visits | Incidence of laboratory visits related to warfarin treatment in warfarin-treated individuals | During warfarin treatment and beyond 6 months after the treatment | |
| Secondary | The number of laboratory tests | 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 | |
| Secondary | Incidence of emergency room (ER) visits | 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 | |
| Secondary | Indicidence of hospital admissions | Hospitalizations caused by bleeding, myocardial infarction or cerebral infarction in warfarin-treated individuals | During warfarin treatment and beyond 6 months after the treatment | |
| Secondary | The number of hospital inpatient days | 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 | |
| Secondary | Incidence of medical procedures | 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 |