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The Stroke–Acute Ischemic NXY Treatment (SAINT) program, sponsored by the pharmaceutical company that provided the study drug, consisted of two randomized, double-blind, placebo-controlled trials. The first one, SAINT I, showed promising results for the free-radical–trapping agent NXY-059 as a neuroprotectant in ischemic stroke patients. To confirm the findings, the SAINT II trial enrolled twice as many patients. Of 3306 patients enrolled from 362 centers in 31 countries, 3241 received either NXY-059 or placebo within 6 hours of stroke onset. Patients who were eligible for tissue plasminogen activator (tPA) received it.
No differences were noted between the placebo and study-drug groups in disability at 90 days (primary outcome) or in rates …