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Pragmatic trial assessing polygenic risk driven statin therapy for cardiovascular disease prevention: study protocol

Ave Voit1, Aet Elken2,3, Margus Viigimaa4,2,5

  • 1University of Tartu Institute of Family Medicine and Public Health, Tartu, Estonia ave.voit@ut.ee.

BMJ Open
|May 27, 2026
PubMed

Insights

This pragmatic trial investigates if polygenic risk scores (PRS) can guide preventive statin therapy to reduce cardiovascular events in high-risk individuals. The study aims to assess PRS effectiveness in real-world primary care settings.

Area of Science:

  • Cardiovascular Medicine
  • Genetics
  • Preventive Healthcare

Background:

  • Atherosclerotic cardiovascular disease (ASCVD) is a major cause of preventable death.
  • Polygenic risk scores (PRS) identify individuals at high ASCVD risk but aren't routinely used.
  • Pragmatic trials are crucial for evaluating PRS integration into primary care.

Purpose of the Study:

  • To evaluate the effectiveness of preventive statin treatment guided by PRS.
  • To reduce cardiovascular events and death in high-risk populations over 5 years.
  • To assess PRS utility in routine cardiovascular disease prevention.

Main Methods:

  • A pragmatic, multicenter, randomized clinical trial with 1:1 allocation.
  • 1350 participants receiving rosuvastatin (intervention) vs. 1350 standard care (control).
  • Primary outcome: time to first major adverse cardiovascular event (MACE).

Main Results:

  • Data on the primary outcome (MACE) and secondary outcomes will be collected over 5 years.
  • Analysis will follow the intention-to-treat principle.
  • Results will inform clinical practice guidelines for PRS implementation.

Conclusions:

  • This trial will provide evidence on the clinical utility of PRS in guiding statin therapy.
  • Findings will contribute to reducing ASCVD burden through personalized prevention strategies.
  • The study addresses the gap in integrating genetic risk information into cardiovascular care.
Abstract

Keywords:
Coronary heart diseasePragmatic Clinical TrialPrimary PreventionRandomized Controlled Trial

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