Evaluating statin treatment in frail older patients after stroke or TIA

StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study

This study is testing whether keeping older, frail patients on statins after a stroke or TIA helps them feel better and avoid serious heart problems compared to stopping the medication.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 70 Years to 120 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 4 sites (Almere Stad and 3 other locations)
• Trial ID: NCT06785740 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the impact of continuing versus discontinuing statin therapy in frail individuals aged 70 and above who have recently experienced an ischemic stroke or transient ischemic attack (TIA). The study will follow participants for two years to evaluate their health-related quality of life and the incidence of major adverse cardiovascular events (MACE). Given the conflicting guidelines on statin use in older patients, this research seeks to fill the gap in evidence regarding the efficacy of statins in frail older adults. Participants will be assessed based on their frailty status using a validated scale.

Who should consider this trial

Good fit: Ideal candidates are frail individuals aged 70 and older who have recently suffered an ischemic stroke or TIA and are currently on statin therapy.

Not a fit: Patients who are very frail with a life expectancy of less than six months or those with serious adverse reactions to statins will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the optimal management of statin therapy in frail older patients, potentially improving their quality of life and reducing adverse cardiovascular events.

How similar studies have performed: While there is limited evidence specifically addressing frail older adults, previous studies have shown that statins can reduce major vascular events in older populations, indicating potential for success in this cohort.

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.

Where this trial is running

Almere Stad and 3 other locations

• Flevoziekenhuis — Almere Stad, Netherlands (Recruiting)
• Amsterdam UMC, location AMC — Amsterdam, Netherlands (Recruiting)
• Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
• Isala Klinieken — Zwolle, Netherlands (Recruiting)

Study contacts

• Principal investigator: Renske van den Berg-Vos, Prof. dr. — Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
• Study coordinator: Susanna R Prins, MSc

Conditions Ischemic Stroke; TIA