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2024-517343-31-00RecruitingPhase 4

StAtins in Frail oldEr patients with ischemic Stroke or Transient ischemic attack – The Randomized Controlled Trial

Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Dec 2025

Next steps

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
600 (estimated)
First submitted
19 Aug 2024
Start date
11 Apr 2025
Lead sponsor
Amsterdam UMC Stichting
Diseases
Stroke
EU CT number
2024-517343-31-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 600
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for frail people aged 70 or older who recently had an ischemic stroke or a transient ischemic attack (TIA) and do not take a statin.

Age
70 years or older at the time of the stroke or TIA.
Sex
All sexes can join.
Disease stage
Ischemic stroke or TIA within the 6 weeks before joining. Frailty on the Clinical Frailty Scale: a score of 4-7 before the event and/or 6-7 after the event.
Earlier treatment
Must not have been taking statin therapy at the time of the stroke or TIA.

Main reasons for not taking part

  • Serious side effects from statins in the past, or another reason statins cannot be used
  • Very severe frailty or life expectancy under 6 months (score of 8 or more on the Clinical Frailty Scale)
  • Cannot communicate in Dutch
  • Cannot answer questions, even with the help of a proxy
  • Cannot or does not want to give written informed consent, even with the help of a proxy

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (23)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Flevoziekenhuis StichtingAlmereNetherlandsRecruiting
Stichting OLVGAmsterdamNetherlandsRecruiting
Amsterdam UMC StichtingAmsterdamNetherlandsRecruiting
Gelre HospitalsApeldoornNetherlandsRecruiting
Rijnstate Ziekenhuis StichtingArnhemNetherlandsRecruiting
Catharina Ziekenhuis StichtingEindhovenNetherlandsRecruiting
Medisch Spectrum TwenteEnschedeNetherlandsRecruiting
UMC GroningenGroningenNetherlandsRecruiting
Zuyderland Medisch Centrum StichtingHeerlenNetherlandsRecruiting
Elkerliek ziekenhuisHelmondNetherlandsRecruiting
Frisius MCLeeuwardenNetherlandsRecruiting
Leids Universitair Medisch Centrum (LUMC)LeidenNetherlandsRecruiting
Academisch Ziekenhuis MaastrichtMaastrichtNetherlandsRecruiting
St. Antonius ZiekenhuisNieuwegeinNetherlandsRecruiting
Sint Franciscus Vlietland Groep StichtingRotterdamNetherlandsRecruiting
Erasmus Medisch Centrum 1RotterdamNetherlandsRecruiting
Maasstad Ziekenhuis StichtingRotterdamNetherlandsRecruiting
Haaglanden Medisch Centrum Stichting'S-GravenhageNetherlandsRecruiting
Jeroen Bosch Ziekenhuis Stichting'S-HertogenboschNetherlandsRecruiting
Stichting Elisabeth-TweeSteden ZiekenhuisTilburgNetherlandsRecruiting
Universitair Medisch Centrum UtrechtUtrechtNetherlandsRecruiting
Stichting Viecuri Medisch Centrum voor Noord-LimburgVenloNetherlandsRecruiting
Isala Klinieken StichtingZwolleNetherlandsRecruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.