Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial, called the SAFEST-cohort study, is investigating the effects of continuing or stopping statin medication in frail older adults who have recently experienced an ischemic stroke or a transient ischemic attack (TIA). Statins are medications commonly used to lower cholesterol, but guidelines on their use in older patients can be confusing. The study aims to see how these different approaches to statin treatment affect the health and quality of life of participants over two years.

To participate, individuals must be 70 years or older, have had a stroke or TIA within the last six weeks, and already be taking statins. They should also be considered frail based on a specific scale that measures their health. Participants will be monitored for changes in their health and well-being during the study. It’s important to note that those with severe health issues or who have had serious reactions to statins in the past cannot join the study. This trial is currently looking for volunteers, so if you or a loved one meet the criteria, you may have the opportunity to contribute to important research in this area.

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;
• • already 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 Scale.
• Exclusion Criteria:
• • Previous serious adverse drug reactions (defined as an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisa-tion, results in persistent or significant disability or incapacity, or is a birth defect32) 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.
• • Inability or unwillingness to provide written informed consent, either independently or with the assistance of a proxy.