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Clinical Trials in the Netherlands / NCT06785740
Recruiting Observational

Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study

NCT06785740 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Observational
Started
2024-11-01
Last updated
2025-01-21

Condition(s) studied

Ischemic StrokeTIA

Investigational drug(s) / intervention(s)

Statin →

Statin: Statin use

Study summary

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.

Eligibility

Sex
ALL
Min age
70 Years
Max age
120 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Health-Related Quality of Life (HrQoL) — 3, 6, 12, 18, 24 (and 36) months
    This will be measured using the PROMIS-10 scale scores (ranging from 0 to 100, with higher scores indicating better health), including global mental health and global physical health subscales. Measurements at 3, 6, 12, 18, 24 (and 36) months. months.
  • Major Adverse Cardiovascular Events (MACE) free survival — 3, 6, 12, 18, 24 (and 36) months
    Classical 3-point MACE (cardiovascular death, nonfatal MI, or nonfatal stroke) and non-cardiovascular death. Measurements at 3, 6, 12, 18, 24 (and 36) months.

Trial sites (4)

FacilityCityRegionStatus
Flevoziekenhuis Almere Stad Netherlands Recruiting
Amsterdam UMC, location AMC Amsterdam Netherlands Recruiting
Catharina Ziekenhuis Eindhoven Netherlands Recruiting
Isala Klinieken Zwolle Netherlands Recruiting

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Other trials for the same condition

Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake Recruiting
Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome Active, not recruiting
Clinical Evaluation of EEG Device for the Triage of Stroke Patients in the Ambulance Recruiting
Observational Dutch Young Symptomatic StrokE studY - nEXT Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06785740 on ClinicalTrials.gov ↗ ← All trials in the Netherlands