Actively Recruiting
Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack A Prospective Cohort Study Evaluating Quality of Life and Cardiovascular Outcomes
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
Researchers are evaluating the impact of continuing versus stopping statin therapy in frail individuals aged 70 and older who have recently experienced an ischemic stroke or transient ischemic attack (TIA). This study addresses the uncertainty in treatment guidelines for older patients because previous statin trials mainly included fit, non-frail adults. The goal is to understand how statin use affects health-related quality of life and the chance of major cardiovascular events in this vulnerable population over two years. Participants in this prospective cohort study will be observed without implementing specific interventions. They will be followed for two years, with some enrolled in the early years being followed for up to three years. During this time, researchers will collect data on statin use, quality of life through questionnaires, the occurrence of major adverse cardiovascular events (MACE), and any changes in treatment. Throughout the study, participants will complete assessments regarding their quality of life and report any cardiovascular events or falls. The main outcomes measured include health-related quality of life and MACE-free survival at multiple time points up to 36 months. This ongoing monitoring aims to provide clearer evidence on the benefits and risks of statin use in frail older adults after stroke or TIA.
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
B
Birgit A Damoiseaux-Volman, PhD
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
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here