{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "University of Tartu Institute of Family Medicine and Public Health, Tartu, Estonia"
      ],
      "name": "Ave Voit"
    },
    {
      "affiliations": [
        "North Estonia Medical Centre Cardiology Centre, Tallinn, Estonia",
        "Institute of Clinical Medicine, University of Tartu, Tartu, Estonia"
      ],
      "name": "Aet Elken"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Family Medicine and Public Health, Tartu, Estonia",
        "North Estonia Medical Centre Cardiology Centre, Tallinn, Estonia",
        "Department of Health Technologies, Tallinn University of Technology, Tallinn, Estonia"
      ],
      "name": "Margus Viigimaa"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Family Medicine and Public Health, Tartu, Estonia"
      ],
      "name": "Ruth Kalda"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Mathematics and Statistics, Tartu, Estonia",
        "University of Tartu Institute of Genomics, Tartu, Estonia"
      ],
      "name": "Krista Fischer"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Family Medicine and Public Health, Tartu, Estonia"
      ],
      "name": "Karolin Toompere"
    },
    {
      "affiliations": [
        "Heart Clinic, Tartu University Hospital, Tartu, Estonia"
      ],
      "name": "Alar Irs"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Genomics, Tartu, Estonia"
      ],
      "name": "Lili Milani"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Genomics, Tartu, Estonia"
      ],
      "name": "Helene Alavere"
    },
    {
      "affiliations": [
        "Institute of Clinical Medicine, University of Tartu, Tartu, Estonia",
        "Genetics and Personalized Medicine Clinic, Tartu University Hospital, Tartu, Estonia"
      ],
      "name": "Sander Pajusalu"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Genomics, Tartu, Estonia"
      ],
      "name": "Elin Org"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Family Medicine and Public Health, Tartu, Estonia"
      ],
      "name": "Janika Alloja"
    },
    {
      "affiliations": [
        "Institute of Clinical Medicine, University of Tartu, Tartu, Estonia",
        "Clinical Research Center, Tartu University Hospital, Tartu, Estonia"
      ],
      "name": "Katrin Kaarna"
    },
    {
      "affiliations": [
        "University of Tartu Institute of Family Medicine and Public Health, Tartu, Estonia"
      ],
      "name": "Mikk Jürisson"
    }
  ],
  "title": "Pragmatic trial assessing polygenic risk driven statin therapy for cardiovascular disease prevention: study protocol for the EE-PRS trial",
  "uid": "380bbe89-df65-5bb7-b4c0-0d5adf861048"
}