Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy

What Was Tested

This registered phase 2 trial tested Cerebrolysin.

Acute ischemic stroke caused by blockage of a large brain artery can lead to severe disability.

Endovascular thrombectomy is a catheter-based procedure used to remove the blood clot and restore blood flow.

It had two arms (groups): Cerebrolysin After Successful Extended-Window Thrombectomy (experimental) and Matched Placebo After Successful Extended-Window Thrombectomy (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study will enroll 100 participants aged 18 to 80 years with anterior-circulation acute ischemic stroke caused by internal carotid artery or M1/M2 middle cerebral artery occlusion.

Eligible participants must undergo endovascular thrombectomy more than 6 hours and no more than 24 hours after stroke onset and must achieve successful reperfusion, defined as modified Thrombolysis in Cerebral Infarction grade 2b or 3, before randomization.

Study treatment will be administered intravenously over 60 minutes once daily for 10 consecutive days and will begin after randomization and within 36 hours of stroke onset.

The primary outcome is final infarct volume measured on diffusion-weighted magnetic resonance imaging performed on Day 7 to Day 10.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 to 80 years. Acute anterior-circulation ischemic stroke caused by internal carotid artery or M1 or M2 middle cerebral artery occlusion confirmed by computed tomography angiography. Stroke onset-to-groin-puncture interval greater than 6 hours and no more than 24 hours. Prestroke modified Rankin Scale score of 0 to 2. Baseline National Institutes of Health Stroke Scale score of at least 6 with cortical signs.

The full record lists 11 inclusion and 10 exclusion criteria; among the exclusions: life expectancy less than 6 months or a serious medical, neurological, or psychiatric condition likely to interfere with study treatment, follow-up, or outcome assessment; current pregnancy or breastfeeding; known iodinated contrast allergy that precludes required endovascular or imaging procedures.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Cerebrolysin group and the comparison group should start out alike.

The Cerebrolysin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cerebrolysin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2026-09-01 with completion listed for 2029-12-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Final Infarct Volume on Diffusion-Weighted MRI (time frame: Day 7 to Day 10 after stroke onset).

It also tracked 6 secondary outcomes, for example Functional Independence Defined as Modified Rankin Scale Score 0-2, Symptomatic Intracranial Hemorrhage, Plasma Claudin-5 Concentration-Time Profile, Montreal Cognitive Assessment Score and Recurrent Stroke.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cerebrolysin in 100 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cerebrolysin compound page, all human trials.