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

Recruiting now

Conditions studied: Ischemic Stroke, TIA

In brief

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.

Key facts

Study ID

NCT06785740

Run by

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

People needed

300

Starts

2024-11-01

Expected to finish

2029-09-01

Last updated by the study team

2025-01-21

Who can join

Age: 70 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Flevoziekenhuis — Almere Stad, Netherlands (enrolling)
• Amsterdam UMC, location AMC — Amsterdam, Netherlands (enrolling)
• Catharina Ziekenhuis — Eindhoven, Netherlands (enrolling)
• Isala Klinieken — Zwolle, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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