Cerebrolysin in Patients With Acute Ischemic Stroke in Asia Results of a Double-Blind, Placebo-Controlled Randomized Trial

Cerebrolysin showed neuroprotective and neurotrophic properties in various preclinical models of ischemia and small clinical trials. The aim of this large double-blind, placebo-controlled randomized clinical trial was to test its efficacy and safety in patients with acute ischemic stroke. Patients w...

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Bibliographic Details
Published in:Stroke (1970) 2012-03, Vol.43 (3), p.630-636
Main Authors: HEISS, Wolf-Dieter, BRAININ, Michael, BORNSTEIN, Natan M, TUOMILEHTO, Jaakko, ZHEN HONG
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Amino Acids - adverse effects
Amino Acids - therapeutic use
Asia
Biological and medical sciences
Brain Ischemia - complications
Brain Ischemia - drug therapy
Brain Ischemia - mortality
Double-Blind Method
Female
Humans
Kaplan-Meier Estimate
Magnetic Resonance Imaging
Male
Medical sciences
Middle Aged
Muscle
Neurology
Neuroprotective Agents - adverse effects
Neuroprotective Agents - therapeutic use
Pharmacology. Drug treatments
Sample Size
Stroke - drug therapy
Stroke - etiology
Stroke - mortality
Surveys and Questionnaires
Survival Analysis
Tomography, X-Ray Computed
Treatment Outcome
Vascular diseases and vascular malformations of the nervous system
Young Adult
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Summary:Cerebrolysin showed neuroprotective and neurotrophic properties in various preclinical models of ischemia and small clinical trials. The aim of this large double-blind, placebo-controlled randomized clinical trial was to test its efficacy and safety in patients with acute ischemic stroke. Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily). The patients were followed up to 90 days. The primary end point was the result of a combined global directional test of modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale. Adverse events were documented to assess safety. A total of 1070 patients were enrolled in this study. Five hundred twenty-nine patients were assigned to Cerebrolysin and 541 to placebo. The confirmatory end point showed no significant difference between the treatment groups. When stratified by severity however, a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale >12 (National Institutes of Health Stroke Scale: OR, 1.27; CI lower bound, 0.97; modified Rankin Scale: OR, 1.27; CI lower bound, 0.90). In this subgroup, the cumulative mortality by 90 days was 20.2% in the placebo and 10.5% in the Cerebrolysin group (hazard ratio, 1.9661; CI lower bound, 1.0013). In this study, the confirmatory end point showed neutral results between the treatment groups. However, a favorable outcome trend was seen in the severely affected patients with ischemic stroke treated with Cerebrolysin. This observation should be confirmed by a further clinical trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00868283.
ISSN:0039-2499
1524-4628
DOI:10.1161/STROKEAHA.111.628537