Skip to content

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517343-31-00
Acronym
NL86273.100.24
Enrollment
600
Registered
2024-12-10
Start date
2025-04-11
Completion date
Unknown
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke and transient ischemic attack

Brief summary

• MACE-free survival over a two-year period, measured at 3, 6, 12, 18, and 24 months, with additional follow-up at three years for those enrolled early in the recruitment phase., • Health-Related Quality of Life (HRQoL) measured using the Patient-Reported Outcomes Measurement Information System - Global-10 (PROMIS-10) at 3, 6, 12, 18, and 24 months, with additional follow-up at three years for those enrolled early in the recruitment phase.

Detailed description

Number of new major cardiovascular events, Cognitive function at 12 and 24 months., Falls (number and time to first fall), Frailty status at 12 and 24 months., Functional outcome at 12 and 24 months.

Interventions

DRUGPravastatine Viatris 10 mg Tabletten
DRUGFluvastatine 20 mg PCH
DRUGRosuvastatine Viatris 5 mg Filmtabletten
DRUGSimvastatine Mylan 40 mg
DRUGfilmomhulde tabletten
DRUGAtorvastatine Viatris 10 mg Filmtabletten

Sponsors

Amsterdam UMC Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• MACE-free survival over a two-year period, measured at 3, 6, 12, 18, and 24 months, with additional follow-up at three years for those enrolled early in the recruitment phase., • Health-Related Quality of Life (HRQoL) measured using the Patient-Reported Outcomes Measurement Information System - Global-10 (PROMIS-10) at 3, 6, 12, 18, and 24 months, with additional follow-up at three years for those enrolled early in the recruitment phase.

Secondary

MeasureTime frame
Number of new major cardiovascular events, Cognitive function at 12 and 24 months., Falls (number and time to first fall), Frailty status at 12 and 24 months., Functional outcome at 12 and 24 months.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026