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Clomethiazole Acute Stroke Study in ischemic stroke (CLASS-I): final results

Authors :
Ashfaq Shuaib
Lawrence R. Wechsler
Patrick D. Lyden
A. Rajput
K. Levin
K. Ng
Richard P. Atkinson
E. Salazar-Grueso
L. Claesson
Tim Ashwood
Tomas Odergren
Source :
Stroke. 33(1)
Publication Year :
2002

Abstract

Background and Purpose — A previous trial (the Clomethiazole Acute Stroke Study) generated the hypothesis that clomethiazole is effective in patients with a major ischemic stroke (total anterior circulation syndrome), and this was tested in the present study. Methods — A total of 1198 patients with major ischemic stroke and a combination of limb weakness, higher cortical dysfunction, and visual field deficits were randomly assigned to clomethiazole (68 mg/kg IV over 24 hours) or placebo. The study drug was initiated within 12 hours of symptom onset. Functional outcome and neurological recovery were assessed at days 7, 30, and 90, with the proportion of patients with a Barthel Index ≥60 at last follow-up as the primary outcome measure. Results — The patients were randomly assigned equally, and the two treatment groups were well matched for baseline characteristics, including stroke severity (mean National Institutes of Health Stroke Scale score 16.9±5.2). Ninety-six percent were classified as total anterior circulation syndrome. The proportion of patients reaching a Barthel Index score of ≥60 was 42% in the clomethiazole-treated group and 46% in the placebo-treated group (odds ratio, 0.81; 95% CI, 0.62 to 1.05; P =0.11). There was no evidence of efficacy on any secondary outcome variables (modified Rankin Score, National Institutes of Health Stroke Scale, Scandinavian Stroke Scale, and 30-day CT infarct volumes) compared with placebo. Subgroup analysis showed a similar lack of treatment effect in patients treated early ( Conclusions — The target population was selected, and sufficient drug was given to produce the expected pharmacological effect in the brain. Clomethiazole does not improve outcome in patients with major ischemic stroke.

Details

ISSN :
15244628
Volume :
33
Issue :
1
Database :
OpenAIRE
Journal :
Stroke
Accession number :
edsair.doi.dedup.....95b20ffe11013b991dfbe84201d52ab8