A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)

What Was Tested

In this not phased trial, researchers set out to test Cerebrolysin.

It had 1 arm (groups): Participants undergo EVT plus Cerebrolysin (experimental).

The registry classes the interventions as drug.

More on the Plan

In patients with AIS after EVT, according to the consensus guidelines, the study drug (Cerebrolysin) will be administered as IV-infusion over 30 minutes.

First treatment will be administered up to 3 hours after completion of the EVT intervention..

First treatment will be given after a post EVT CT-Perfusion was performed.

The treatment with Cerebrolysin will be repeated until day 10 as a single daily infusion.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Female or male inpatients. Age: ≥18 years. Clinical diagnosis of ischemic stroke eligible for EVT. No contraindication to undergo CT-Perfusion.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: participation in another therapeutic clinical trial 3 months before baseline; female patient of childbearing age must not be pregnant as proved by beta-hgb negative testing; platelet count of below 100x103/mm3.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Cerebrolysin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-10-01 with completion listed for 2024-06-30.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Modified Rankin Scale (mRS) (time frame: 90 Days).

It also tracked 5 secondary outcomes, for example NIH Stroke Scale (NIHSS), Glasgow Outcome Score, Geriatric Depression Scale (GDS), Montreal Cognitive Assessment (MoCA) and Short Form 36 Health Survey (SF36).

What This Means in Plain Language

Put simply, this is a not phased trial of Cerebrolysin in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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