NXY-059 for the treatment of acute stroke: pooled analysis of the SAINT I and II Trials

TLDR: NXY-059 is ineffective for treatment of AIS within 6 hours of symptom onset and this is also true for subgroups and the prevention of alteplase-associated hemorrhage.

Abstract: Background and Purpose— In animal models of acute ischemic stroke (AIS), the free radical–trapping agent NXY-059 showed promise as a neuroprotectant. SAINT I and II were randomized, placebo-controlled, double-blind trials to investigate the efficacy of NXY-059 in patients with AIS. Methods— Patients with AIS received an infusion of intravenous NXY-059 or placebo within 6 hours from the onset of stroke symptoms. A pooled individual patient analysis was prespecified to assess the overall efficacy and to examine subgroups. The primary end point was the distribution of disability scores measured on the modified Rankin scale (mRS) at 90 days. Neurologic and activities of daily living scores were investigated as secondary end points. We also evaluated whether treatment with NXY-059 would reduce alteplase-related intracranial hemorrhages. Finally, we evaluated possible predictors of good or poor outcome. Results— An intent-to-treat efficacy analysis was based on 5028 patients. Baseline parameters and prognostic ...