Conflict of interest: None.
A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with Acute ischaemic Stroke in Asia – CASTA
Article first published online: 16 SEP 2009
© 2009 The Authors. © 2009 World Stroke Organization
International Journal of Stroke
Volume 4, Issue 5, pages 406–412, October 2009
How to Cite
Hong, Z., Moessler, H., Bornstein, N., Brainin, M., Heiss, W.-D. and for the CASTA-Investigators (2009), A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with Acute ischaemic Stroke in Asia – CASTA. International Journal of Stroke, 4: 406–412. doi: 10.1111/j.1747-4949.2009.00340.x
Funding: The study is funded by EBEWE Neuro Pharma GmbH.
- Issue published online: 16 SEP 2009
- Article first published online: 16 SEP 2009
- clinical trial;
- infarct progression;
- ischaemic stroke;
- multimodal action;
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.