A Randomized, ASA-Controlled Trial of Mesoglycan in Secondary Prevention after Cerebral Ischemic Events

Abstract

The aim of this randomized, open, parallel-group study was to compare the efficacy and tolerability of mesoglycan, a glycosaminoglycan preparation, and acetylsalicylic acid (ASA) in prevention of vascular events after cerebral ischemic events. In 48 collaborating centers we followed a total of 1,398 patients with recent episodes of reversible ischemic attacks or stroke of atherothrombotic origin, randomized to mesoglycan (701 patients) or ASA (697 patients). During the observation period patients'' new events were recorded: primary outcome events were considered reversible ischemic neurologic deficits, stroke, acute myocardial infarction or death from other vascular causes. At the end of the follow-up period (median duration 18 months) the number of primary outcome events observed in the two treatment groups was similar (68 in the ASA, 70 in the mesoglycan group). Major stroke was observed in 24 patients of the ASA group and in 26 of the mesoglycan group, while deaths from vascular causes were 37 and 32, respectively. Log-rank statistics failed to evidence significant differences between treatment groups. On the other hand, a significantly (p < 0.01, chi square test) higher incidence of side effects was reported in the ASA group (146 vs. 50). The findings of the present investigation are promising and suggest that further studies on mesoglycan as an antithrombotic agent in the secondary prevention of vascular events are warranted.