NXY-059 for Acute Ischemic Stroke

Abstract

Section Editors: Marc Fisher MD Kennedy Lees MD The SAINT I article reports the results of a phase III trial of the free-radical-spin trap, neuroprotective agent, NXY-059 in acute ischemic stroke. The study had a statistically significant effect on the primary outcome measure, the range of 90-day outcomes on the modified Rankin Scale (mRS), a measure of functional outcome after stroke. The change in National Institutes of Health Stroke Scale (NIHSS) scores from baseline, the principal secondary outcome variable, was not effected by treatment with NXY-059. The primary outcome measure used in this trial is novel and has not to my knowledge been used in prior acute stroke trials. The observation in a post hoc analysis of a significant reduction of symptomatic and asymptomatic hemorrhage with NXY-059 in patients who were treated with IV tissue plasminogen activator (t-PA) is also encouraging. It suggests that NXY-059 could be a useful adjunct in stroke patients treated with IV recombinant t-PA to reduce hemorrhagic risk, if reproduced. The primary outcome measure of a shift in the mRS in a favorable direction …