{
  "abstract": "Introduction Statin therapy is known to reduce subsequent cardiovascular events in patients who had an ischaemic stroke and transient ischaemic attack (TIA). However, its effectiveness and safety in frail older adults with a recent stroke or TIA are uncertain, leading to variations in clinical practice. ‘StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack–the Randomized Controlled Trial’ (SAFEST-RCT) aims to investigate the effectiveness of initiating versus not initiating statin therapy in this vulnerable population, to optimise secondary prevention strategies.Methods and analysis This multicentre, prospective, randomised, open-label study aims to enrol 612 frail adults ≥70 years with a recent acute ischaemic stroke or TIA across 22 Dutch hospitals. The study compares prescribing versus not prescribing statins in terms of health-related quality of life, major adverse cardiovascular event-free survival and societal costs over a 2-year follow-up period.Ethics and dissemination The SAFEST-RCT protocol was approved by the Ethics Committee of Amsterdam UMC. It complies with the Declaration of Helsinki and is classified as a healthcare evaluation. Recruitment began in March 2025. Results will be published in open access journals, presented at conferences, shared via the Dutch Brain Injury Association and integrated into national guidelines to support implementation in routine care.Trial registration number NCT06785727.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, Amsterdam UMC Locatie AMC, Amsterdam, Netherlands"
      ],
      "name": "Susanna Rosa Prins"
    },
    {
      "affiliations": [
        "Department of Medical Informatics, Amsterdam UMC, Amsterdam, Netherlands",
        "Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands"
      ],
      "name": "Birgit A Damoiseaux-Volman"
    },
    {
      "affiliations": [
        "Department of Neurology, Rijnstate Hospital, Arnhem, Netherlands"
      ],
      "name": "Sarah E Vermeer"
    },
    {
      "affiliations": [
        "Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam, Netherlands"
      ],
      "name": "Patrick M M Bossuyt"
    },
    {
      "affiliations": [
        "Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam, Netherlands"
      ],
      "name": "Rik Van Eekelen"
    },
    {
      "affiliations": [
        "Department of Health Sciences, Amsterdam Public Health Research Institute, Amsterdam, Netherlands"
      ],
      "name": "Judith E Bosmans"
    },
    {
      "affiliations": [
        "Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands",
        "Expertise Centre for Pharmacotherapy in Older People (Ephor), Amsterdam, Netherlands"
      ],
      "name": "Eveline P Van Poelgeest"
    },
    {
      "affiliations": [
        "Department of Cardiology, Amsterdam UMC Locatie AMC, Amsterdam, Netherlands"
      ],
      "name": "Fabrice M A C Martens"
    },
    {
      "affiliations": [
        "Department of Geriatrics, University Medical Center Utrecht, Utrecht, Netherlands"
      ],
      "name": "Marielle H Emmelot-Vonk"
    },
    {
      "affiliations": [
        "Department of Neurology, Rijnstate Hospital, Arnhem, Netherlands"
      ],
      "name": "Esther Verstraete"
    },
    {
      "affiliations": [
        "Departments of Internal Medicine and Geriatrics, Amsterdam UMC, Amsterdam, Netherlands"
      ],
      "name": "Majon Muller"
    },
    {
      "affiliations": [
        "Department of General Practice, Amsterdam UMC, Amsterdam, Netherlands",
        "Department of Public and Occupational Health, Amsterdam UMC, Amsterdam, Netherlands"
      ],
      "name": "Eric P Moll Van Charante"
    },
    {
      "affiliations": [
        "Dutch Brain Injury Association (Hersenletsel.nl), Velp, Netherlands"
      ],
      "name": "Michiel Lindhout"
    },
    {
      "affiliations": [
        "Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, Netherlands",
        "Departments of Internal Medicine and Geriatrics, Amsterdam UMC, Amsterdam, Netherlands"
      ],
      "name": "Nathalie Van Der Velde"
    },
    {
      "affiliations": [
        "Department of Neurology, Amsterdam UMC Locatie AMC, Amsterdam, Netherlands",
        "Department of Neurology, OLVG Hospital, Amsterdam, Netherlands"
      ],
      "name": "Renske M Van Den Berg-Vos"
    }
  ],
  "title": "Rationale and design of ‘StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack–the Randomized Controlled Trial’ (SAFEST-RCT)",
  "uid": "d963a4fb-b45d-5a12-abc2-9b0e2ba6af2f"
}