Unauthorized organization.Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB) This copyrighted material is provided by Natural Medicines Comprehensive Database Consumer Version. Thrombolytic agents, hemodilution, and drugs acting on the cerebral vasculature were forbidden.Study assessments were performed 1 and 3 days and 1, 2, 4, 8, and 12 weeks after the start of treatment. Outcome was analyzed in all patients and in an “early treatment” subgroup planned in the study protocol to include those treated within 6 hours of stroke onset. A randomized, placebo-controlled, multicenter study, the Piracetam Acute Stroke Study II (PASS II), will soon begin.The following principal investigators and clinical centers participated in the Piracetam in Acute Stroke Study (PASS):The Cochran-Mantel-Haenszel test was used for both comparisons.The study was supported by a grant from UCB Pharma, Braine-l’Alleud, Belgium. Patients with moderate to severe deficits at the onset of stroke have been shown to be more responsive to drug effect in previous trials.One planned interim analysis was performed on the results in the first 514 patients using significance levels of α=.005 for efficacy and α=.05 for safety parameters. We are indebted to Dr Betty Van Vleymen and Dr R.S. Investigators were neurologists, internists, or gerontologists from 55 hospitals in 10 European countries. Neurologic status evaluated by the Middle Cerebral Artery neurologic scaleThe Barthel Index has been widely used to assess functional outcome or activities of daily living in the evaluation of stroke. 2000;181(1-2):65-72. We therefore included patients treated within 12 hours of onset and also planned a subgroup analysis in patients treated until 6 hours after the onset of stroke, a period subsequently redefined as less than 7 hours. Tolerance was good in this trial as in other studies in acute strokeInitial severity of stroke and age are the strongest predictors of mortality after stroke.Post hoc analyses in the early treatment subgroup showed a trend toward improvement in favor of pira-cetam. (check all that apply) BACKGROUND: Piracetam has neuroprotective and antithrombotic effects that may help to reduce death and disability in people with acute stroke. Mortality within 12 weeks was 23.9% (111/464) in the piracetam group and 19.2% (89/463) on placebo. Members of the latter were otherwise unconnected with the project, and their functions included review of deaths and serious adverse events and, in the event of untoward findings, termination of the trial. They were frequently recorded to the nearest 15 minutes. In these patients, stroke was more severe at baseline in the piracetam group (mean Orgogozo scale score: piracetam, 28.7±25.0; placebo, 38.4±37.5).The early treatment population consisted of 452 patients (224 piracetam, 228 placebo) whose baseline characteristics were similar in each group and differed in no significant respect from the total population. The Barthel Index was therefore modified so that patients scored as 100 and without neurologic abnormality (Orgogozo scale, 100) received a score of 110, and patients who died, a score of −10. We found differences in neurologic outcome favoring piracetam in this subgroup. Packard for their help in preparing the manuscript. Patients who can perform all specified activities unaided receive a score of 100 but may remain handicapped by neurologic impairments even though they are independent in daily activities. For professional medical information on natural medicines, see Natural Medicines Comprehensive Database Professional Version.WebMD does not provide medical advice, diagnosis or treatment.This survey is being conducted by the WebMD marketing sciences department.All information will be used in a manner consistent with the WebMD Thus, when outcomes in the early treatment subgroup were related to the initial severity of stroke, differences favoring piracetam were confined to patients with moderate and marked neurologic impairment defined by an Orgogozo scale score <55 and were minimal in the presence of milder deficits (baseline Orgogozo scale, ≥55).