StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Randomized Controlled Trial

Launched by PROF. DR. NATHALIE VAN DER VELDE · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial, called the SAFEST - RCT, is studying the effects of starting statin medication in older, frail patients who have recently experienced an ischemic stroke or a transient ischemic attack (TIA). Statins are drugs often used to lower cholesterol and reduce the risk of heart problems. The goal of the trial is to find out if taking a statin can improve the quality of life and reduce serious heart-related events over a two-year period for individuals aged 70 and older.

To be eligible for this trial, participants need to be at least 70 years old, have had a stroke or TIA within the last six weeks, and not be currently taking statins. They should also be considered frail, which is assessed using a specific scoring system. Throughout the trial, participants will be monitored to see how they respond to the treatment. It’s important to note that this trial is not yet recruiting participants, so there will be more opportunities to learn about it in the future. If you or someone you know fits the eligibility criteria, it could be a chance to contribute to important research that may help improve care for older patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age = 70 years or older at the time of ischemic stroke or TIA;
• • inclusion within 6 weeks after diagnosis of ischemic stroke or TIA;
• • not using statin therapy at the time of the index event;
• • frailty as defined by a pre-event score of 4-7 and/or post-event score of 6-7 on the validated Clinical Frailty Scfale.\[49\]
• Exclusion Criteria:
• • Patients with a stroke or TIA of non-atherosclerotic etiology.
• • Previous serious adverse drug reactions (defined as an adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect40) to statins or other contraindications to statin use.
• • Very severe frailty or very limited life expectancy (\< 6 months) as defined by a score \>= 8 points on the validated Clinical Frailty Scale.
• • Inability to communicate in Dutch.
• • Inability to respond to questions, either independently or with the assistance of a proxy (a proxy is allowed to assist by writing on behalf of the participant in cases of physical incapacity or by discussing questions with the participant, but the proxy cannot make decisions for the participant).
• • Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy (a proxy is allowed to assist by writing on behalf of the participant in cases of physical incapacity or by discussing the consent form with the participant, but the proxy cannot make decisions or provide consent on behalf of the participant).
• • Extremely high-risk patients, i.e. patients who have had two or more cardiovascular events within a period of one year.