ORIGINAL RESEARCH article

Front. Neurol.

Sec. Stroke

Volume 16 - 2025 | doi: 10.3389/fneur.2025.1582513

Efficacy of argatroban plus alteplase according to time from onset to thrombolysis in acute ischemic stroke: A prespecified post-hoc analysis of the ARAIS trial

Provisionally accepted
Yu  CuiYu Cui1,2Er-Qiang  WangEr-Qiang Wang3Yi-Hang  WangYi-Hang Wang2Hui-Sheng  ChenHui-Sheng Chen2*
  • 1Northern Theater Command General Hospital, Shenyang, China
  • 2General Hospital of Northern Theater Command, Shenyang, China
  • 3Fuqing Hospital, Fuqing, China

The final, formatted version of the article will be published soon.

The ARAIS trial failed to demonstrate the benefit of argatroban in patients diagnosed with acute ischemic stroke who were treated with intravenous alteplase. A post-hoc analysis was conducted to investigate whether the time from onset to thrombolysis (OTT) affected the outcomes.The included patients were classified into two subgroups according to OTT. The primary outcome was an excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 or 1. The efficacy of argatroban plus alteplase was investigated in each subgroup compared with alteplase alone.Overall, 696 patients were included: 452 were assigned to the OTT <180 min subgroup, and 244 to the OTT ≥180 min subgroup. The treatment effect of argatroban plus alteplase was similar to that of alteplase alone in the OTT <180 min subgroup (adjusted RD [95% CI] = 0.5% [-5.6% to 6.6%]) and OTT ≥180 min subgroup (adjusted RD [95% CI] = -1.3% [-9.8% to 7.1%]). No significant interaction between the treatment efficacy and OTT was found (P=0.75).The prespecified secondary analysis indicated that the efficacy of argatroban plus alteplase did not differ according to OTT in terms of 90-day excellent functional outcomes compared with alteplase alone.

Keywords: Acute ischemic stroke, Argatroban, alteplase, OTT, clinical outcomes

Received: 24 Feb 2025; Accepted: 20 May 2025.

Copyright: © 2025 Cui, Wang, Wang and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Hui-Sheng Chen, General Hospital of Northern Theater Command, Shenyang, China

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