Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.

What Was Tested

This registered phase 3 trial tested Cerebrolysin.

The primary outcome measure will be overall proportion of subjects receiving Cerebrolysin comparing to control group experiencing a favorable functional outcome (by modified Rankin Scale \[mRS\] 0-2) at 7 day, 30 days, 90 days and 12 months following stroke onset.

It had two arms (groups): active (experimental) and historical control (no intervention).

Historical data will be obtained by retrospective clinical chart reviews of patients hospitalized in the study center between 2017 and Dec.2020 and fulfilling the same clinical and radiological inclusion criteria in whom 12-month follow-up (including mRS, NIHSS, BI, EQ-5D-5L) could be obtained.

The registry classes the interventions as drug.

More on the Plan

The mechanisms underlying this "no-reflow phenomenon" are thought to result from altered microvascular circulation, proinflammatory state and thrombosis that can persist despite proximal recanalization.

Mechanical revascularization presents a proven procedure with no potential drug-drug interactions, that can be administered in series or parallel with neuroprotective agents.

Cerebrolysin is a neuropeptide preparation produced by standardized enzymatic breakdown of porcine brain proteins.

All the patients (including those from the control group) will receive the same standardized rehabilitation program (including speech therapy, occupational and physical therapy) during hospitalization at Stroke Unit and at Neurorehabilitation Clinic until day 90 according to local procedures.

Who Took Part

The registry lists 50 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 18-80 years. Signs and symptoms consistent with the diagnosis of an anterior circulation AIS. MRS ≤1 prior to qualifying stroke (functionally independent for all ADLs). Moderate to severe stroke: NIHSS score of ≥5 with presence of any cortical signs (gaze, visual fields, language, or neglect). Initiation of treatment with Cerebrolysin ≤8h following stroke onset (Cerebrolysin group).

The full record lists 12 inclusion and 12 exclusion criteria; among the exclusions: other serious, advanced, or terminal illness or life expectancy ≤ 6 months; pregnancy or lactation; known allergy to iodine that precludes an endovascular procedure.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

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 2021-01-01 with completion listed for 2023-12-31.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Favorable functional outcome (time frame: 7 days - 12 months).

It also tracked 7 secondary outcomes, for example Distribution of the modified Rankin Scale (mRS), Proportion of symptomatic intracranial hemorrhage (sICH), Final infarct volume (mL), Penumbral salvage (mL) and Infarct growth (mL).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Cerebrolysin in 50 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.