StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack – The Randomized Controlled Trial
Key facts
- Where
- 'S-Gravenhage, 'S-Hertogenbosch, Almere, Amsterdam, Apeldoorn, Arnhem, Eindhoven, Enschede, Groningen, Heerlen, Helmond, Leeuwarden, Leiden, Maastricht, Nieuwegein, Rotterdam, Tilburg, Utrecht, Venlo és Zwolle, HollandiaSee the 23 sites
- Phase
- 4. fázis
Where in Hollandia
- Haaglanden Medisch Centrum Stichting'S-Gravenhage, HollandiaTaking people
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, HollandiaTaking people
- Flevoziekenhuis StichtingAlmere, HollandiaTaking people
- Amsterdam UMC StichtingAmsterdam, HollandiaTaking people
- Stichting OLVGAmsterdam, HollandiaTaking people
- Gelre HospitalsApeldoorn, HollandiaTaking people
- Rijnstate Ziekenhuis StichtingArnhem, HollandiaTaking people
- Catharina Ziekenhuis StichtingEindhoven, HollandiaTaking people
- Medisch Spectrum TwenteEnschede, HollandiaTaking people
- UMC GroningenGroningen, HollandiaTaking people
- Zuyderland Medisch Centrum StichtingHeerlen, HollandiaTaking people
- Elkerliek ziekenhuisHelmond, HollandiaTaking people
- Frisius MCLeeuwarden, HollandiaTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, HollandiaTaking people
- St. Antonius ZiekenhuisNieuwegein, HollandiaTaking people
- Erasmus Medisch Centrum 1Rotterdam, HollandiaTaking people
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaTaking people
- Sint Franciscus Vlietland Groep StichtingRotterdam, HollandiaTaking people
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, HollandiaTaking people
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaTaking people
- Stichting Viecuri Medisch Centrum voor Noord-LimburgVenlo, HollandiaTaking people
- Isala Klinieken StichtingZwolle, HollandiaTaking 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
- Amsterdam UMC Stichting
- Trial code
- EU 2024-517343-31-00
- Record updated
- 2025. december 17.
- Original description
To evaluate the effect of initiating statin therapy versus no statin therapy on Major Adverse Cardiovascular Events (MACE)-free survival and health-related quality of life (HRQoL) over a two-year follow-up in frail individuals aged 70 and above with a recent ischemic stroke or TIA.Read full original descriptionShow less
To evaluate the effect of initiating statin therapy versus no statin therapy on Major Adverse Cardiovascular Events (MACE)-free survival and health-related quality of life (HRQoL) over a two-year follow-up in frail individuals aged 70 and above with a recent ischemic stroke or TIA.
Inclusion: A recent ischemic stroke or TIA (within 6 weeks before inclusion); Age equal to or greater than 70 years at the time of the ischemic stroke or TIA; Frailty, as defined by a pre-event score of 4-7 and/or a post-event score of 6-7 on the validated Clinical Frailty Scale; Not using statin therapy at the time of the index event.
Exclusion: Previous serious adverse drug reactions (defined as an adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitaliza-tion, results in persistent or significant disability or incapacity, or is a birth defect) 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.