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Citation: JNS Volume 187, Supplement 1, page S436, June 2001

M.G. Hennerici¹, J. Bogousslavsky², G.L. Lenzi³, G.M. Orgogozo

¹Universitätsklinikum Mannheim, Germany
²Department of Neurology, Lausanne, Switzerland
³Department of Neurology, Rome, Italy
⁴Department of Neurology, Bordeaux, France

Objective: Comparison of Ancrod vs placebo treatment in a double-blind design to determine outcome in patients with ischemic stroke treated within six hours.
Background: Ancrod has been reported recently to show an advantage of treatment given within 3 hours from stroke onset, which extends already known benefits of tPA in the same time window. Insufficient data exists on a six-hour time window.
Design/Methods: ESTAT is a phase III trial performed in Europe as well as in Australia and Israel, investigating patients with ischaemic stroke within six hours after onset of symptoms. Patients (>18 years) with sudden stroke-related neurological deficits and the baseline Scandinavian Stroke Scale (SSS) score excluding the gait item <40 were randomly assigned to Ancrod and placebo treatment within six hours after recognized onset of stroke. Symptoms had to last longer than 30 minutes without significant improvement. Before treatment a CT was performed to exclude intracranial hemorrhage and evolving large ischaemic infarcts. Treatment consisted of continuous infusion for 72 hours, followed by a daily single iv infusion for two days to reach and maintain a fibrinogen level of 40­70 mg/dl.
Results: Recruitment started in July 1996, enrollment stopped at the end of March 2000 after 1222 patients in 16 countries and 101 centres were recruited. Primary outcome for efficacy was defined as Barthel index 95­100 or return to pre-stroke values after 3 months. Secondary endpoints are SSS, Rankin Scale and death after 3 months and outcome after one year.
Conclusions: Pending outcome of analyses for the main ESTAT hypotheses.