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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70-120
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

300 Participants
are divided into 2 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