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ENROLLING BY INVITATION
NCT06820086
PHASE4

Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

Sponsor: Mikk JÜRISSON

View on ClinicalTrials.gov

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.

Official title: The Pragmatic EE-PRS Trial Assessing Polygenic Risk Driven Statin Therapy for Cardiovascular Disease Prevention

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2025-04

Completion Date

2033-02

Last Updated

2025-03-25

Healthy Volunteers

No

Interventions

DRUG

Rosuvastatin 20mg

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

Locations (2)

North Estonia Medical Centre

Tallinn, Harju, Estonia

Tartu University Hospital

Tartu, Tartu, Estonia