Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
300 participants
Nov 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
Statin use
Locations(4)
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NCT06785740