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

Summary

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.

Conditions

• Stroke, Ischemic
• Stroke, Acute
• Stroke Sequelae

Interventions

DRUG

Cerebrolysin

neuroprotection treatment

Sponsors & Collaborators

• Brainomix Limited

  collaborator INDUSTRY

• Military Institute od Medicine National Research Institute

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-12-31

Completion

2024-12-31

Countries

• Poland

Study Locations