Actively Recruiting

Age: 70Years - 120Years
All Genders
NCT06785740

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

Age: 70Years - 120Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study | DecenTrialz