6/28/23, 11:22 PM NINDS Pathway Feedback Search Clinical Topics Home Studies NINDS NINDS Disease Acute ischemic stroke Trial question What is the role of tPA in patients with ischemic stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 42.0% female N = 624 58.0% male 624 patients (260 female, 364 male) Inclusion criteria: patients with ischemic stroke Key exclusion criteria: receipt of anticoagulants or heparin within the 48 hours preceding the onset of stroke, PTs > 15 seconds, platelet counts < 100,000/mm , or glucose concentrations < 50 mg/dL or > 400 mg/dL Interventions N=312 tPA (alteplase at a dose of 0.9 mg/kg of body weight, maximum 90 mg) N=312 placebo (matching placebo) Primary outcome Death at 90 days https://web.pathway.md/studies/recrgZrUrrnKm83sH 1/2 6/28/23, 11:22 PM NINDS Pathway 21.0 % 21 17 15.8 % 10.5 % 5.3 % No significant difference 0.0 % Tissue plasminogen activator Placebo No significant difference in death at 90 days (17% vs. 21%; RR 0.81, 95% CI -0.71 to 2.33) Safety outcomes Significant differences in symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke (6.4% vs. 0.6%, p < 0.001). Conclusion In patients with ischemic stroke, tPA was superior to placebo with respect to death at 90 days. Reference National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. Open reference URL https://web.pathway.md/studies/recrgZrUrrnKm83sH 2/2