Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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.