EFFICACY AND SAFETY OF CEREBROLYSIN AFTER FUTILE RECANALISATION THERAPY IN PATIENTS WITH SEVERE STROKE (ID 1065)
Abstract
Background And Aims
Golden standard of acute stroke treatment is recanalisation
therapy. However, opening the occluded blood vessel sometimes does
not show the expected clinical result or leads to haemorrhagic
complications. As neuroinflammation and neurotoxicity play an important
role in the pathophysiology of stroke, neuroprotective agents might
preserve brain tissue after futile recanalisation.
Methods
After recanalisation therapy and not later than 24
hours after symptoms onset, patients with initial NIHSS of ≥8 were
assigned to the investigational and control group. The investigational
group received intravenous Cerebrolysin as add-on therapy. The primary
objective was to assess the clinical efficacy of Cerebrolysin. The
secondary objective was to investigate its effect on haemorrhagic
transition and to confirm its safety profile.
Results
Baseline characteristics of patients showed no significant
differences between the two groups. No difference could be detected
between the two groups in the mRS scale though the Cerebrolysin group
showed descriptive superiority over the control group. We found a
statistically significant difference considering haemorrhagic transition and
mortality rate in favour of the Cerebrolysin group.
Conclusions
The multimodal neurotrophic agent Cerebrolysin holds
promise to impact on the late consequences of a reperfusion syndrome.
We also confirmed the excellent safety profile
of Cerebrolysin. Finaly, Cerebrolysin as add-on therapy might be beneficial and safe
for patients with acute stroke in terms of lowering risk for haemorrhagic
complications after recanalisation therapy.
Trial Registration Number
ISRCTN 15233803
https://doi.org/10.1186/ISRCTN15233803