LSTM Home > LSTM Research > LSTM Online Archive

Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke: The ARAIS Randomized Clinical Trial.

Chen, Hui-Sheng, Cui, Yu, Zhou, Zhong-He, Dai, Ying-Jie, Li, Gao-Hua, Peng, Zhao-Long, Zhang, Yi, Liu, Xiao-Dong, Yuan, Zhi-Mei, Jiang, Chang-Hao, Yang, Qing-Cheng, Duan, Ying-Jie, Ma, Guang-Bin, Zhao, Li-Wei, Wang, Rui-Xian, Sun, Yuan-Lin, Shen, Lei, Wang, Er-Qiang, Wang, Li-Hua, Feng, Ye-Fang, Wang, Feng-Yun, Zou, Ren-Lin, Yang, He-Ping, Wang, Kai, Wang, Duolao ORCID: and Wang, Yi-Long (2023) 'Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke: The ARAIS Randomized Clinical Trial.'. The Journal of the American Medical Association (JAMA), Vol 329, Issue 8, pp. 640-650.

JAMA-Chen et al.pdf - Accepted Version

Download (6MB) | Preview


Previous studies suggested a benefit of argatroban plus alteplase (recombinant tissue-type plasminogen activator) in patients with acute ischemic stroke (AIS). However, robust evidence in trials with large sample sizes is lacking. To assess the efficacy of argatroban plus alteplase for AIS. This multicenter, open-label, blinded end point randomized clinical trial including 808 patients with AIS was conducted at 50 hospitals in China with enrollment from January 18, 2019, through October 30, 2021, and final follow-up on January 24, 2022. Eligible patients were randomly assigned within 4.5 hours of symptom onset to the argatroban plus alteplase group (n = 402), which received intravenous argatroban (100 μg/kg bolus over 3-5 minutes followed by an infusion of 1.0 μg/kg per minute for 48 hours) within 1 hour after alteplase (0.9 mg/kg; maximum dose, 90 mg; 10% administered as 1-minute bolus, remaining infused over 1 hour), or alteplase alone group (n = 415), which received intravenous alteplase alone. Both groups received guideline-based treatments. The primary end point was excellent functional outcome, defined as a modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]) of 0 to 1 at 90 days. All end points had blinded assessment and were analyzed on a full analysis set. Among 817 eligible patients with AIS who were randomized (median [IQR] age, 65 [57-71] years; 238 [29.1%] women; median [IQR] National Institutes of Health Stroke Scale score, 9 [7-12]), 760 (93.0%) completed the trial. At 90 days, 210 of 329 participants (63.8%) in the argatroban plus alteplase group vs 238 of 367 (64.9%) in the alteplase alone group had an excellent functional outcome (risk difference, -1.0% [95% CI, -8.1% to 6.1%]; risk ratio, 0.98 [95% CI, 0.88-1.10]; P = .78). The percentages of participants with symptomatic intracranial hemorrhage, parenchymal hematoma type 2, and major systemic bleeding were 2.1% (8/383), 2.3% (9/383), and 0.3% (1/383), respectively, in the argatroban plus alteplase group and 1.8% (7/397), 2.5% (10/397), and 0.5% (2/397), respectively, in the alteplase alone group. Among patients with acute ischemic stroke, treatment with argatroban plus intravenous alteplase compared with alteplase alone did not result in a significantly greater likelihood of excellent functional outcome at 90 days. Identifier: NCT03740958.

Item Type: Article
Corporate Authors: ARAIS Investigators
Subjects: QV Pharmacology > QV 38 Drug action.
WL Nervous System > WL 300 General works (Include works on brain alone)
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):
SWORD Depositor: JISC Pubrouter
Depositing User: JISC Pubrouter
Date Deposited: 27 Feb 2023 13:48
Last Modified: 04 Apr 2023 13:15


View details

Actions (login required)

Edit Item Edit Item