6/28/23, 10:09 PM EXTEND Pathway Feedback Search Clinical Topics Home Studies EXTEND EXTEND Disease Acute ischemic stroke Trial question What is the effect of alteplase between 4.5 and 9.0 hours after the onset of ischemic stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 44.0% female N = 225 56.0% male 225 patients (100 female, 125 male) Inclusion criteria: patients with ischemic stroke who had hypoperfused but salvageable regions of brain detected on automated perfusion imaging Key exclusion criteria: investigator consideration of the use of endovascular thrombectomy at the time of enrollment, intracranial hemorrhage, rapidly improving symptoms, previous stroke within last three months Interventions N=113 alteplase (intravenous administration of 0.9 mg/kg of body weight, maximum 90 mg, between 4.5 and 9.0 hours of stroke onset or on awakening with stroke) N=112 placebo (matching placebo between 4.5 and 9.0 hours of stroke onset or on awakening with stroke) Primary outcome Modified Rankin Scale score of 0 or 1 at 90 days https://web.pathway.md/studies/recsEBzmZ4JFQ7h6N 1/2 6/28/23, 10:09 PM EXTEND Pathway 35.4 % 35.4 29.5 26.5 % 17.7 % Significant increase 8.8 % NNH = 17 0.0 % Alteplase Placebo Significant increase in mRS score of 0 or 1 at 90 days (35.4% vs. 29.5%; aRR 1.44, 95% CI 1.01 to 2.06) Secondary outcomes Borderline significant increase in functional independence, a mRS score of 0 to 2 (49.6% vs. 42.9%; aRR 1.36, 95% CI 1.06 to 1.76) Borderline significant increase in reperfusion of at least 50% at 24 hours (71.7% vs. 52.3%; aRR 1.35, 95% CI 1.09 to 1.67) Borderline significant increase in recanalization at 24 hours after stroke (67.3% vs. 39.4%; aRR 1.68, 95% CI 1.29 to 2.19) Safety outcomes No significant difference in death within 90 days. Significant difference in symptomatic intracranial hemorrhage within 36 hours (6.2% vs. 0.9%). Conclusion In patients with ischemic stroke who had hypoperfused but salvageable regions of brain detected on automated perfusion imaging, alteplase was superior to placebo with respect to mRS score of 0 or 1 at 90 days. Reference Henry Ma, Bruce C V Campbell, Mark W Parsons et al. Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke. N Engl J Med. 2019 May 9;380(19):1795-1803. Open reference URL https://web.pathway.md/studies/recsEBzmZ4JFQ7h6N 2/2