BACKGROUND Piracetam has neuroprotective and antithrombotic effects which may help to reduce death and disability in people with acute stroke. OBJECTIVE The objective of this review was to assess the effects of piracetam in acute presumed ischaemic stroke. METHODS We searched the Cochrane Stroke Group Trials Register (last searched 20 June 2005). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to April 2005), EMBASE (1980 to April 2005), and ISI Science Citation Index (1981 to April 2005). We also contacted the manufacturer of piracetam to identify further published and unpublished studies. METHODS Randomised trials comparing piracetam with control, with at least mortality reported and entry to the trial within approximately 48 hours of stroke onset. METHODS Two authors extracted data and assessed trial quality and this was checked by the other two authors. Study authors were contacted for missing information. RESULTS Three trials involving 1002 people were included, with one trial contributing 93% of the data. Participants' ages ranged from 40 to 85, and both sexes were equally represented. Piracetam was associated with a statistically non-significant increase in death at one month (approximately 31% increase, 95% confidence interval 81% increase to 5% reduction). This trend was no longer apparent in the large trial after correction for imbalance in stroke severity. Limited 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. CONCLUSIONS There is some suggestion (but no statistically significant result) of an unfavourable effect of piracetam on early death, but this may have been caused by baseline differences in stroke severity in the trials. There is not enough evidence to assess the effect of piracetam on dependency.