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

Recruitingn/aAges 70 Years - 120 YearsAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Statin
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Where

4 sites
Flevoziekenhuis
Almere Stad, Netherlands
Amsterdam UMC, location AMC
Amsterdam, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Isala Klinieken
Zwolle, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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