Journal article

Randomized, Placebo-Controlled, Dose-Ranging Clinical Trial of Intravenous Microplasmin in Patients With Acute Ischemic Stroke

Vincent NS Thijs, Andre Peeters, Milan Vosko, Franz Aichner, Peter D Schellinger, Dietmar Schneider, Tobias Neumann-Haefelin, Joachim Roether, Antoni Davalos, Nils Wahlgren, Peter Verhamme

Stroke | LIPPINCOTT WILLIAMS & WILKINS | Published : 2009

Abstract

BACKGROUND AND PURPOSE: Microplasmin is a recombinant truncated form of human plasmin. It has demonstrated efficacy in experimental animal models of stroke and tolerability in healthy volunteers. We tested the tolerability of microplasmin in patients with acute ischemic stroke. METHODS: In a multicenter, double-blind, randomized, placebo-controlled Phase II trial, 40 patients with ischemic stroke were treated with either placebo or active drug between 3 and 12 hours after symptom onset in a dose-finding design. Ten patients received placebo, 6 patients received a total dose of 2 mg/kg, 12 patients received a total dose of 3 mg/kg, and 12 patients received a total dose of 4 mg/kg. We studied ..

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