A Cochrane review included 3 studies with a total of 1 002 subjects with acute stroke. One randomized, placebo-controlled, double-blind, multicenter trial contributed 93% of the data. Piracetam given i.v. within 48 hours of acute stroke was associated with a statistically non-significant increase in death at one month (OR 1.32, 95% CI 0.96 to 1.82). This trend was no longer apparent in the large trial after correction for imbalance in stroke severity. The data showed no difference between the treatment and control groups for functional outcome, dependency or proportion of patients dead or dependent. Adverse effects were not reported.