Statins in frail older adults after ischemic stroke or transient ischemic attack
Follows frail older adults after stroke on or off statins.
Plain-language title generated from the registry record
Registry title: Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
Key facts
- Where
- Almere Stad, Amsterdam, Eindhoven, and Zwolle, NetherlandsSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 70 and 120 years old?
Source: NCT06785740, who can take part
Where in Netherlands
- FlevoziekenhuisAlmere Stad, NetherlandsTaking people
- Amsterdam UMC, location AMCAmsterdam, NetherlandsTaking people
- Catharina ZiekenhuisEindhoven, NetherlandsTaking people
- Isala KliniekenZwolle, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Trial code
- NCT06785740
- Record updated
- 21 January 2025
- Original description
Two Dutch guidelines (Stroke and Cardiovascular Risk Management) provide conflicting advice on optimal statin treatment in older patients. In the SAFEST-cohort, the investigators will assess the impact of continuing versus discontinuing a statin in frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA) on their health-related quality of life and MACE free survival during a two-year follow-up period.Read full original descriptionShow less
StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
Two Dutch guidelines (Stroke and Cardiovascular Risk Management) provide conflicting advice on optimal statin treatment in older patients. In the SAFEST-cohort, the investigators will assess the impact of continuing versus discontinuing a statin in frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA) on their health-related quality of life and MACE free survival during a two-year follow-up period.
Inclusion: 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: 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.