Evaluating statin treatment in frail older patients after stroke or TIA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: s.r.prins@amsterdamumc.nl
• Phone: 0031 20 566 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.