Abstract
The CLASS study showed no significant difference between treatment groups for the neuroprotectant clomethiazole compared with placebo. However, a beneficial effect of the drug was seen in patients with total anterior circulation syndrome (TACS). These are patients with clinical symptoms suggesting a large stroke. Full results of this subgroup analysis are reported. Patients were classified before randomization using clinical symptoms into the stroke syndromes TACS, partial anterior circulation syndrome, and lacunar syndrome. Subgroup analyses of stroke syndromes were performed post hoc after detecting a treatment by severity interaction. The primary efficacy variable was relative functional independence defined as the proportion of patients scoring > or =60 on the Barthel Index at 90 days. TACS patients (n=546, 40% of all CLASS patients) were more severe at baseline on the 58 point Scandinavian Stroke Scale compared with non-TACS patients (median difference 10 points, mean difference 10.9 points, SE=0.6). Outcome for TACS patients treated with placebo was poor, with only 29.8% reaching relative functional independence. This was increased to 40.8% in the clomethiazole group, a 37% relative benefit, which is clinically significant (odds ratio=1.62, 95% CI 1.13-2.31, nominal P=.008). There was little or no difference in the outcome of non-TACS patients treated with clomethiazole compared with placebo. The treatment effect in TACS patients was quite consistent across participating countries and the 3 parts of the study defined by the 2 interim analyses. The treatment effect seen in patients with clinical symptoms suggesting a large stroke (TACS) is biologically plausible but requires confirmation in a prospective study which is ongoing.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.