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Clomethiazole Acute Stroke Study in ischemic stroke (CLASS-I): final results
- 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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Time Factors
Subgroup analysis
Placebo
law.invention
Brain Ischemia
Randomized controlled trial
Double-Blind Method
law
Clomethiazole
Medicine
Humans
Adverse effect
GABA Modulators
Stroke
Aged
Advanced and Specialized Nursing
business.industry
Odds ratio
Middle Aged
medicine.disease
Surgery
Clinical trial
Neuroprotective Agents
Anesthesia
Acute Disease
Female
Neurology (clinical)
Cardiology and Cardiovascular Medicine
business
Chlormethiazole
medicine.drug
Subjects
Details
- ISSN :
- 15244628
- Volume :
- 33
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Stroke
- Accession number :
- edsair.doi.dedup.....95b20ffe11013b991dfbe84201d52ab8