About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Statin
Treatment groups
Sponsors and collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Amsterdam UMC, location AMC
Sponsor institution
VU University of Amsterdam
Collaborator