Actively Recruiting
Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-01-21
300
Participants Needed
4
Research Sites
252 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
V
VU University of Amsterdam
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older at the time of ischemic stroke or TIA
- Inclusion within 6 weeks after diagnosis of ischemic stroke or TIA
- Currently using statin therapy at the time of the stroke or TIA
- Frailty defined by a Clinical Frailty Scale score of 4-7 before the event or 6-7 after the event
You will not qualify if you...
- History of serious adverse reactions to statins or other reasons preventing statin use
- Very severe frailty or life expectancy less than 6 months (Clinical Frailty Scale score 8 or higher)
- Inability to communicate in Dutch
- Unable to respond to questions independently or with assistance
- Unable or unwilling to provide informed consent independently or with help
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Flevoziekenhuis
Almere Stad, Netherlands
Actively Recruiting
2
Amsterdam UMC, location AMC
Amsterdam, Netherlands
Actively Recruiting
3
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
4
Isala Klinieken
Zwolle, Netherlands
Actively Recruiting
Research Team
S
Susanna R Prins, MSc
CONTACT
B
Birgit A Damoiseaux-Volman, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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