More on stroke

As if to illustrate the problems in running stroke trials, Boehringer Ingelheim GmbH on Friday announced negative preliminary results of its European Cooperative Acute Stroke Study II (ECASS II) of Alteplase tissue plasminogen activator. Boehringer Ingelheim (Ingelheim, Germany) has a European license to Alteplase from Genentech Inc.

The placebo-controlled trial evaluated 0.9 mg/kg Alteplase to a maximum dose of 90 mg in 800 patients who experienced onset of stroke symptoms within the prior 6 hours. The primary end point - the proportion of patients with no or minimal functional deficit at day 90 as assessed by the Modified Rankin Scale - did not achieve statistical significance. The company noted an unexpectedly high placebo response and a low overall mortality compared with previous stroke trials. No difference was seen in mortality between the Altaplase and placebo groups...