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Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

NCT06820086 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2714

Last updated 2026-05-13

No results posted yet for this study

Summary

This research investigates the potential advantages of intensive preventive statin treatment for healthy men aged 45-80 and women aged 55-80 who possess a high genetic predisposition to coronary artery disease (CAD). By specifically targeting the top 20% of individuals with elevated CAD polygenic risk scores (PRS), the study seeks to find out whether this tailored approach can notably decrease the occurrence of cardiovascular disease and mortality over a five-year period when compared with usual care. Despite the potential of PRS in pinpointing individuals at heightened risk for cardiovascular disease, there is a lack of focused and prospective investigations in existing research. This study aims to bridge this gap by examining whether preventive statin therapy for individuals with high CAD PRS is not only effective in diminishing cardiovascular events but also economically viable. The comparison between the statin treatment arm and standard care practice is conducted in a pragmatic manner at the primary care level.

Conditions

  • PRS-based Primary Prevention of CVD

Interventions

DRUG

Rosuvastatin 20mg

Preventive statin treatment with rosuvastatin 20mg, 1 tablet per day, for healthy individuals with top 20% CAD PRS.

Sponsors & Collaborators

  • Funding: European Union (the sponsor does not fund the study)

    collaborator UNKNOWN

  • The Estonian Health Insurance Fund

    collaborator UNKNOWN

  • North Estonian Medical Center

    collaborator UNKNOWN

  • Tartu University Hospital

    collaborator OTHER

  • Mikk JÜRISSON

    lead OTHER

Principal Investigators

  • Mikk Jürisson, PhD · Institute of Family Medicine and Public Health, University of Tartu

  • Aet Elken (Saar), PhD · Heart Clinic, Tartu University Hospital

  • Margus Viigimaa, PhD · North Estonia Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2031-03-31
Completion
2034-03-31

Countries

  • Estonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06820086 on ClinicalTrials.gov