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A randomized trial of tirilazad mesylate in patients with acute stroke (RANTTAS) The RANTTAS Investigators äStroke 1996[Sep]; 27 (9): 1453-8BACKGROUND AND PURPOSE: Tirilazad mesylate, a nonglucocorticoid 21-aminosteroid lipid peroxidation inhibitor, has shown promise as a neuroprotectant in experimental models of focal cerebral ischemia. METHODS: To test whether early treatment with tirilazad, 6 mg/kg per day for 3 days, would improve functional outcome after acute human stroke, 27 North American centers conducted a prospective, randomized, double-blinded, vehicle-controlled trial in patients with acute stroke treated within 6 hours of onset. The primary outcome measures were disability as measured by the Glasgow Outcome Scale and activities of daily living by the Barthel Index determined 3 months after stroke. RESULTS: From May 1993 through December 1994, 660 patients were randomized. The trial was prematurely terminated on the advice of an independent monitoring committee after review of outcome data at a preplanned interim analysis. In 556 fully eligible patients (276 tirilazad, 280 vehicle), the odds ratio of a favorable outcome in favor of tirilazad was 0.87 (95% confidence interval [CI], 0.60 to 1.25) for the Glasgow Outcome Scale and 0.87 (95% CI, 0.60 to 1.25) for the Barthel Index, after adjustment for imbalances between the groups in preexisting disability, prior stroke, and diabetes. CONCLUSIONS: These observations suggest that tirilazad, 6 mg/kg per day for 3 days administered beginning at a median of 4.3 hours after stroke, does not improve overall functional outcome.|Activities of Daily Living[MESH]|Aged[MESH]|Antioxidants/*therapeutic use[MESH]|Cerebrovascular Disorders/*drug therapy/physiopathology[MESH]|Double-Blind Method[MESH]|Female[MESH]|Glasgow Coma Scale[MESH]|Humans[MESH]|Injections, Intravenous[MESH]|Lipid Peroxides/antagonists & inhibitors[MESH]|Male[MESH]|Middle Aged[MESH]|Pregnatrienes/*therapeutic use[MESH]|Prospective Studies[MESH]|Survival Analysis[MESH]|Time Factors[MESH]|Treatment Outcome[MESH] |
