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StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Randomized Controlled Trial

NCT06785727 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2025-01-21

No results posted yet for this study

Summary

Two Dutch guidelines (Stroke and Cardiovascular Risk Management) provide conflicting advice on optimal statin treatment in older patients. In the SAFEST - RCT, the investigators will assess the impact of starting versus not starting 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 Major Adverse Cardiovascular Events (MACE) free survival during a two-year follow-up period.

Conditions

Interventions

DRUG

Statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin or simvastatin)

The intervention group receives statin treatment following the current "Herseninfarct en Hersenbloeding" guideline. The intensity and target value of statin treatment are determined according to this national guideline. Which statin (atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin) will be selected and what dose will be prescribed is left to the discretion of the treating neurologist. The statins are registered in the Netherlands and use will be according to the licenses of the products. They will be collected at the local pharmacy by the patient (following practice as usual).

Sponsors & Collaborators

  • VU University of Amsterdam

    collaborator OTHER

  • Prof. dr. Nathalie van der Velde

    lead OTHER

Principal Investigators

  • Renske van den Berg, Prof. dr. · Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

  • Nathalie van der Velde, Prof. dr. · Amsterdam UMC, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2028-12-01
Completion
2029-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06785727 on ClinicalTrials.gov