A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of cerebrolysin in patients with Acute ischaemic Stroke in Asia - CASTA

Z. Hong, H. Moessler, N. Bornstein, M. Brainin, W. D. Heiss

Research output: Contribution to journalArticlepeer-review

Abstract

Cerebrolysin has exhibited neuroprotective as well as neurotrophic properties in various animal models of cerebral ischaemia and has shown clinical efficacy and good safety in several small controlled clinical studies in ischaemic stroke. Therefore, a large double-blind placebo-controlled randomized clinical trial was launched in Asia to prove the validity of this treatment strategy. In the more than 50 participating centres patients with acute ischemic hemispheric stroke are randomized within 12 hours of symptoms onset to treatment (30 ml Cerebrolysin diluted in physiologic saline) or placebo (saline) given as intravenous infusion once daily added to standard care for 10 days. The patients are followed with regular visits for 90 days. Efficacy is evaluated on day 90 by three outcome scales - modified Rankin Scale, Barthel Index and NIH Stroke Scale - combined to single global directional test. Additionally, adverse events are documented to prove safety. In this study a total of 1060 patients will be included and analysis of data will be completed in 2010. If positive, this trial will add an effective strategy to the treatment of acute ischaemic stroke.

Original languageEnglish
Pages (from-to)406-412
Number of pages7
JournalInternational Journal of Stroke
Volume4
Issue number5
DOIs
StatePublished - Oct 2009
Externally publishedYes

Keywords

  • Cerebrolysin
  • Clinical trial
  • Infarct progression
  • Ischaemic stroke
  • Multimodal action
  • Neuroplasticity

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