NCT06785740 Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
| NCT ID | NCT06785740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-11-01 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Renske van den Berg-Vos, Prof. dr.
PRINCIPAL INVESTIGATOR
Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Frequently Asked Questions
Who can join the NCT06785740 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, up to 120 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06785740 currently recruiting?
Yes, NCT06785740 is actively recruiting participants. Contact the research team at s.r.prins@amsterdamumc.nl for enrollment information.
Where is the NCT06785740 trial being conducted?
This trial is being conducted at Almere Stad, Netherlands, Amsterdam, Netherlands, Eindhoven, Netherlands, Zwolle, Netherlands.
Who is sponsoring the NCT06785740 clinical trial?
NCT06785740 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Renske van den Berg-Vos, Prof. dr. at Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. The trial plans to enroll 300 participants.
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