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NOT YET RECRUITING
NCT06785727
PHASE4

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

Sponsor: Prof. dr. Nathalie van der Velde

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

70 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

612

Start Date

2025-02-01

Completion Date

2029-07-01

Last Updated

2025-01-21

Healthy Volunteers

No

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).