Key result
Trial evaluates preventive rosuvastatin versus standard care to reduce MACE in high polygenic risk patients.
Why the study?
Polygenic risk scores can detect individuals at higher risk of ASCVD, but they have not yet been integrated into routine clinical practice.
Does preventive rosuvastatin 20 mg reduce major adverse cardiovascular events in men and women with a high coronary artery disease polygenic risk score?
RCT (n=2,700)
Open-label
1:1
Yes
Does preventive rosuvastatin 20 mg reduce major adverse cardiovascular events in men and women with a high coronary artery disease polygenic risk score?
This study protocol describes a pragmatic trial to evaluate the effectiveness of polygenic risk score-driven rosuvastatin therapy for primary cardiovascular prevention.
Planned RCT tests PRS-guided rosuvastatin for primary prevention; leaves open whether high PRS identifies responsive patients.
Introduction Atherosclerotic cardiovascular disease (ASCVD) continues to be a leading cause of preventable death globally. Polygenic risk scores (PRS) offer a way to detect individuals at higher relative risk of developing ASCVD, but they have not yet been incorporated into routine clinical practice. Pragmatic trials offer a way to evaluate the integration of PRS into cardiovascular disease prevention in primary care, allowing for a more accurate assessment of their effectiveness in everyday clinical practice. Methods and analysis This trial evaluates the effectiveness of preventive statin treatment on reducing the incidence of cardiovascular events and death over 5 years in women (aged 55–80) and men (aged 45–80) with a high coronary artery disease PRS. This is a pragmatic, multicentre, open-label, parallel group, randomised clinical trial with a 1:1 allocation ratio to intervention (n=1350), receiving preventive rosuvastatin 20 mg treatment or control (n=1350), receiving current standard of care. Following the intention-to-treat principle, all randomised participants are analysed according to their allocated group, with the primary outcome defined as time to first major adverse cardiovascular event, comprising ischaemic heart disease, stroke or transient ischaemia, peripheral vascular occlusion and stenosis, revascularisation or cardiovascular death. Ethics and dissemination This trial has received ethical approval from the Estonian Committee on Bioethics and Human Research (13.06.2024 nr 1.1-12/1531) and the Estonian Ethics Committee for Medicinal Products (19.12.2024 nr RKU-4/92). Trial registration number NCT06820086 .
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Voit et al. (2026) conducted an RCT in Cardiovascular disease prevention (n=2,700). Rosuvastatin vs. Current standard of care was evaluated on Time to first major adverse cardiovascular event (ischaemic heart disease, stroke or transient ischaemia, peripheral vascular occlusion and stenosis, revascularisation or cardiovascular death). Preventive rosuvastatin 20 mg will be evaluated against standard of care for reducing cardiovascular events over 5 years in 2,700 patients with high polygenic risk scores.
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