6/28/23, 12:43 AM ARAIS Pathway Feedback Search Clinical Topics Home Studies ARAIS ARAIS Disease Acute ischemic stroke Trial question What is the role of argatroban plus intravenous alteplase in patients with acute ischemic stroke? Study design Multi-center Open label RCT Population Characteristics of study participants 29.1% female N = 696 70.9% male 696 patients (238 female, 579 male) Inclusion criteria: adult patients with acute ischemic stroke who were assigned within 4.5 hours of symptom onset Key exclusion criteria: presence of disability in the community before the stroke; history of intracerebral hemorrhage; gastrointestinal or urinary tract bleeding in the last 30 days; need for concomitant use of anticoagulants other than argatroban Interventions N=329 argatroban plus alteplase (intravenous argatroban within 1 hour after intravenous alteplase) N=367 alteplase alone (intravenous alteplase) https://web.pathway.md/studies/receXbbrp6p1NU5PF 1/2 6/28/23, 12:43 AM ARAIS Pathway Primary outcome Excellent functional outcome at day 90 64.9 % 64.9 63.8 48.7 % 32.5 % 16.2 % No significant difference 0.0 % Argatroban plus alteplase Alteplase alone No significant difference in excellent functional outcome at day 90 (63.8% vs. 64.9%; RR 0.98, 95% CI 0.88 to 1.1) Secondary outcomes No significant difference in mRS score of 0-2 within 90 (76% vs. 76.3%; RR 1, 95% CI 0.92 to 1.08) No significant difference in early neurologic improvement within 48 hours (69% vs. 67.9%; RR 1.03, 95% CI 0.84 to 1.27) No significant difference in early neurologic deterioration within 48 hours (3.6% vs. 5.1%; RR 0.71, 95% CI 0.36 to 1.4) Safety outcomes No significant difference in symptomatic intracranial hemorrhage; parenchymal hematoma type 2; major systemic bleeding. Conclusion In adult patients with acute ischemic stroke who were assigned within 4.5 hours of symptom onset, argatroban plus alteplase was not superior to alteplase alone with respect to excellent functional outcome at day 90. Reference Hui-Sheng Chen, Yu Cui, Zhong-He Zhou et al. Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke: The ARAIS Randomized Clinical Trial. JAMA. 2023 Feb 9;e230550. Open reference URL https://web.pathway.md/studies/receXbbrp6p1NU5PF 2/2