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Randomized Controlled Trial
. 2025 Oct;39(10):1037-1046.
doi: 10.1007/s40263-025-01211-6. Epub 2025 Aug 4.

Dual Antiplatelet Therapy Versus Alteplase for Mild Stroke with Admission NIHSS Score 0-3 Versus 4-5: A Secondary Analysis of the ARAMIS Randomized Trial

Zhao-Xia Fei #  1 , Yue Yin #  1 , Yu Cui  1 , Thanh N Nguyen  2 , Hui-Sheng Chen  3
Affiliations
Randomized Controlled Trial

Dual Antiplatelet Therapy Versus Alteplase for Mild Stroke with Admission NIHSS Score 0-3 Versus 4-5: A Secondary Analysis of the ARAMIS Randomized Trial

Zhao-Xia Fei et al. CNS Drugs. 2025 Oct.

Abstract

Background: The ARAMIS trial demonstrated the non-inferiority of dual antiplatelet therapy (DAPT) to alteplase in patients with minor nondisabling ischemic stroke. We aimed to investigate whether the degree of neurological deficit can affect the benefit of DAPT versus alteplase.

Methods: On the basis of the as-treated analysis set, eligible patients with acute minor nondisabling stroke were divided into NIHSS 0-3 and NIHSS 4-5 groups, which was further subdivided into DAPT and alteplase groups. The primary outcome was excellent functional outcome, defined as a mRS score of 0-1 at 90 days, and the safety outcome was symptomatic intracerebral hemorrhage (sICH).

Results: A total of 719 patients were enrolled, including 585 in the NIHSS 0-3 group and 134 in the NIHSS 4-5 group. In the NIHSS score 0-3 group, the proportion of patients with mRS of 0-1 at 90 days was 95.5% (277/290) in the DAPT group and 92.2% (272/295) in the alteplase group. In the NIHSS score 4-5 group, the proportion of patients with mRS of 0 or 1 at 90 days was 82.7% (43/52) in the DAPT group and 90.2 % (74/82) in the alteplase group. A significant interaction effect was identified between the baseline NIHSS and treatment for the primary outcome (P = 0.048). There was no patient with sICH in the DAPT group. In the alteplase group, there were three and one patients with sICH in the NIHSS score 0-3 group and 4-5 group, respectively.

Conclusions: Among patients with minor nondisabling acute ischemic stroke presenting within 4.5 h of symptom onset, the benefit of DAPT versus alteplase may be affected by the degree of neurological deficit on admission. DAPT may be favored in patients with a mild neurologic deficit, while alteplase is favored in patients with a higher degree of neurologic deficit. Trial Registration ClinicalTrials.gov Identifier: NCT03661411.

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Conflict of interest statement

Declarations. Funding: This study was supported by grants from the Science and Technology Project Plan of Liaoning Province (2024JH6/100700015). The funders of the study had no role in the study design, data collection, data analysis, data interpretation or writing of the report. Conflict of Interest: T.Nguyen discloses Associate Editorship of Stroke; advisory board for Brainomix, Aruna Bio; speaker for Genentech, Kaneka. Z.X.F. and Y.Y declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript. Authors’ Contributions: H.S.C. contributed to the conception and design of the study, and critically revised the manuscript; Z.X.F. and Y.Y. contributed to analysis of data and drafting the text. Y.C. contributed to analysis of data. T.N.N. critically revised the manuscript. Data Availability Statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. Ethics Approval: This study was performed according to the Declaration of Helsinki and approved by the Ethics Committees of the General Hospital of Northern Theater Command. The ethics committee approval number is k(2018)22 Code Availability: Not applicable. Consent to Participate: Written informed consent was obtained from the patient or their legally authorized representatives. Consent for Publication: Not applicable.

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