NCT04904341

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

Status unknown Phase 3 Last updated 24 August 2022

What this trial tests

Phase 3 trial testing Cerebrolysin in Stroke, Ischemic in 50 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
31 December 2023

31 December 2024

Quick facts

Lead sponsor	Military Institute od Medicine National Research Institute
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 January 2021
Primary completion	31 December 2023
Estimated completion	31 December 2024
Sites	1 location across Poland

Drugs / interventions tested

• Cerebrolysin — full drug profile →

Conditions studied

• Stroke, Ischemic — all drugs for Stroke, Ischemic →
• Stroke, Acute — all drugs for Stroke, Acute →
• Stroke Sequelae — all drugs for Stroke Sequelae →

Sponsor

Military Institute od Medicine National Research Institute

Who can join

Adults 18 to 80, any sex, with Stroke, Ischemic or Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to determine the efficacy and safety of Cerebrolysin treatment as an add- on therapy to mechanical thrombectomy (MT) in reducing global disability in subjects with acute ischemic stroke (AIS). The investigators have planned a single centre, prospective, open-label, single-arm study with 12 months follow-up of 50 patients with moderate to severe AIS, with a small established infarct core and with good collateral circulation who achieve significant reperfusion following MT and who receive additional Cerebrolysin within 8 hours of stroke onset compared to 50 historical controls treated with MT alone - matched for age, clinical severity, occlusion location, baseline perfusion lesion volume, onset to reperfusion time and use of iv thrombolytic therapy (rt-PA).

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. The secondary objectives are to determine the efficacy of Cerebrolysin as compared to control group in reducing risk of symptomatic secondary hemorrhagic transformation, improving neurological outcome (NIHSS 0-2 at day 7, day 30 and 90); reducing mortality rates (over the 90-day and 12 months study period); and improving: activities of daily living (by Barthel Index; BI), health-related quality of life (as measured by the EQ-5D-5L) assessed at day 30, 90 and at 12 months. The other measures of efficacy in Cerebrolysin group will include: assessment of final stroke volume and penumbral salvage (measured by CT/CTP at 30 days) and its change compared to baseline volume, changes over time in language function (by the 15-item Boston Naming Test), hemispatial neglect (by line bisection test), global cognitive function (by The Montreal Cognitive Assessment) and depression (by Hamilton Depression Rating Scale) between day 30 and day 90 assessments). The patients will receive 30 ml of Cerebrolysin within 8h of AIS stroke onset and continue treatment once daily until day 21 (first cycle) and they will receive a second cycle of treatment (30 ml/d for 21 days given in the Outpatient Department or Neurorehabilitation Clinic) from day 69 to 90 (± 3 days). All the patients (including those from the control group) 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. Historical data will be obtained by retrospective clinical chart reviews of patients hospitalized in the study center between Jan.2018 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Systematic Review - Combining Neuroprotection With Reperfusion in Acute Ischemic Stroke.
   Vos EM, Geraedts VJ, van der Lugt A, Dippel DWJ, et al · · 2022 · cited 24× · PMID 35370911 · DOI 10.3389/fneur.2022.840892
2. Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion: Study Protocol for a Prospective, Open Label, Single-Center Study With 12 Months of Follow-Up.
   Staszewski J, Stȩpień A, Piusińska-Macoch R, Dȩbiec A, et al · · 2022 · cited 17× · PMID 35860483 · DOI 10.3389/fneur.2022.910697
3. Adjunctive cytoprotective therapies in acute ischemic stroke: a systematic review.
   Mulder IA, van Bavel ET, de Vries HE, Coutinho JM. · · 2021 · cited 15× · PMID 34666786 · DOI 10.1186/s12987-021-00280-1
4. Cerebrolysin for acute ischaemic stroke.
   Ziganshina LE, Abakumova T, Nurkhametova D, Ivanchenko K. · · 2023 · cited 14× · PMID 37818733 · DOI 10.1002/14651858.cd007026.pub7
5. Nanotechnology approaches to drug delivery for the treatment of ischemic stroke.
   Peng B, Mohammed FS, Tang X, Liu J, et al · · 2025 · cited 13× · PMID 39386225 · DOI 10.1016/j.bioactmat.2024.09.016
6. Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients with Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a 3-Month Follow-up of a Prospective, Open Label, Single-Center Study.
   Staszewski J, Dębiec A, Strilciuc S, Gniadek-Olejniczak K, et al · · 2025 · cited 6× · PMID 40325343 · DOI 10.1007/s12975-025-01355-z
7. Cerebrolysin after Endovascular Thrombectomy in Stroke: 12‑Month Functional Outcomes in a Propensity‑Matched Cohort.
   Staszewski J, Dębiec A, Gniadek-Olejniczak K, Stępień A, et al · · 2026 · PMID 41739286 · DOI 10.1007/s12975-026-01414-z
8. Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion in Anterior Circulation: Results of a three-month follow-up of a Prospective, Open Label, Single-Center Study
   Staszewski J, Dębiec A, Strilciuc S, Gniadek-Olejniczak K, et al · · 2025 · DOI 10.1101/2025.02.14.25322320