Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT

What Was Tested

This registered phase 2, phase 3 trial tested Cerebrolysin.

Cerebrolysin that was proven to have s neuroprotective and neurotrophic effects in vitro and in vivo, administered in combination with endovascular therapy (EVT) could have a positive impact on the prognosis and outcome of these patients.

It had two arms (groups): G1 : Treatment Group (TG)r (active comparator) and G2 : Control Group (CG) (no intervention).

Patients in CG receive no additional i.v. treatment.

The registry classes the interventions as drug.

More on the Plan

In proposed project the researchers evaluate the impact of the combination of early reperfusion therapy (thrombectomy) with early neuroproptective drug administration on treatment results in patients with acute ischemic stroke.

Material and method 100 patients will be qualified for the proposed project.

Patients from both groups G1 and G2 will undergo thrombectomy treatment, and then, depending on the clinical condition, hospitalized in the Intensive Care Unit or the Department of Neurology with the Stroke Department.

During the hospitalization, the standard and typical care for both departments will be continued.

Who Took Part

Enrollment: 100 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: Acute ischemic stroke diagnosis,. Qualification for mechanical thrombectomy, without previous thrombolysis.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: age \<18; cerebrolysin allergy; renal failure.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Cerebrolysin and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Cerebrolysin study: the participants and staff both knew the treatment.

It started in 2021-04-27 with completion listed for 2023-04-01.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Survival (time frame: 6 months). NIHSS (time frame: day 1). NIHSS (time frame: month 3).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cerebrolysin in 100 people.

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.