Rationale and design of 'StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack-the Randomized Controlled Trial' (SAFEST-RCT).

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.