drugset / Trial / NCT06820086

Polygenic Risk Driven Pragmatic Statin Trial for Heart Disease Prevention

NCT06820086

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosuvastatin Small molecule 20 mg

Indications

No indication recorded.