6/28/23, 9:49 PM ECASS III Pathway Feedback Search Clinical Topics Home Studies ECASS III ECASS III Disease Acute ischemic stroke Trial question What is the effect of intravenous alteplase administered after 3 to 4.5 hours in patients with acute ischemic stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 40.0% female N = 821 60.0% male 821 patients (326 female, 495 male) Inclusion criteria: patients with ischemic stroke Key exclusion criteria: intracranial hemorrhage or major ischemic infarction as detected on CT scan, seizure at the onset of stroke, stroke or serious head trauma within the previous 3 months, OAC treatment, or increased risk of bleeding Interventions N=418 alteplase (intravenous dose of 0.9 mg/kg of body weight) N=403 placebo (identical placebo IV) Primary outcome Modified Rankin Scale score of 0 or 1 52.4 % 52.4 45.2 39 3 % https://web.pathway.md/studies/recS1lrKXdXYG7A01 1/2 6/28/23, 9:49 PM 39.3 % ECASS III Pathway 26.2 % Significant increase 13.1 % NNH = 14 0.0 % Alteplase Placebo Significant increase in mRS score of 0 or 1 (52.4% vs. 45.2%; OR 1.34, 95% CI 1.02 to 1.76) Safety outcomes No significant differences in mortality (7.7% vs. 8.4%, p=0.68) and other serious adverse events. Significant differences in any intracranial hemorrhage (27.0% vs. 17.6%, p = 0.001) and symptomatic intracranial hemorrhage (2.4% vs. 0.2%, p = 0.008). Conclusion In patients with ischemic stroke, alteplase was superior to placebo with respect to mRS score of 0 or 1. Reference Hacke W, Kaste M, Bluhmki E et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. Open reference URL https://web.pathway.md/studies/recS1lrKXdXYG7A01 2/2