---
title: Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland
nct_id: NCT04001166
overall_status: COMPLETED
sponsor: VTT Technical Research Centre of Finland
study_type: OBSERVATIONAL
primary_condition: Individuals With a Disease of Cardiovascular System
countries: Finland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04001166.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04001166"
ct_last_update_post_date: 2020-05-19
last_seen_at: "2026-05-12T06:22:18.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland

**Official Title:** Pharmacogenomics of Antithrombotic Drugs (PreMed PGx Study)

**NCT ID:** [NCT04001166](https://clinicaltrials.gov/study/NCT04001166)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 7005
- **Lead Sponsor:** VTT Technical Research Centre of Finland
- **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
- **Conditions:** Individuals With a Disease of Cardiovascular System
- **Start Date:** 2019-10-15
- **Completion Date:** 2020-04-28
- **CT.gov Last Update:** 2020-05-19

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Interventions

- **Non-interventional study** (OTHER) — This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.

## Primary Outcomes

- **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 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)_

## Locations (1)

- 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.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` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04001166.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04001166*  
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