Randomized Clinical Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 16, 2023; 11(32): 7814-7821
Published online Nov 16, 2023. doi: 10.12998/wjcc.v11.i32.7814
Efficacy and safety of aspirin antiplatelet therapy within 48 h of symptom onset in patients with acute stroke
Jian-Quan Zhang, Zhi-Bin Pan
Jian-Quan Zhang, Department of Emergency Medicine, The First Affiliated Hospital of Jiangxi Medical College, Shangrao 334000, Jiangxi Province, China
Zhi-Bin Pan, Department of Neurology, Jiujiang First People's Hospital, Jiujiang 332100, Jiangxi Province, China
Author contributions: Zhang JQ proposed the concept of this study; Zhang JQ and Pan ZB contributed to data collection; Zhang JQ contributed to formal analysis; Pan ZB participated in the survey; Zhang JQ contributed to the methods; Zhang JQ guided the research; Zhang JQ and Pan ZB validated this study; Zhang JQ and Pan ZB contributed to the visualization of this study; Zhang JQ prepared the first draft; Zhang JQ and Pan ZB jointly reviewed and edited the manuscript.
Institutional review board statement: This study obtained the ethical review and approval of the First Affiliated Hospital of Jiangxi Medical College.
Clinical trial registration statement: This study has been registered at the Clinical Research Registry at www.researchregistry.com. The registration identification number is (researchregistry9015).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare that there are no conflicts of interest to disclose.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Jian-Quan Zhang, MSc, Associate Chief Physician, Department of Emergency Medicine, The First Affiliated Hospital of Jiangxi Medical College, No. 31 Qingfeng Road, Shangrao 334000, Jiangxi Province, China. tuju0931042072@126.com
Received: September 25, 2023
Peer-review started: September 25, 2023
First decision: October 17, 2023
Revised: October 18, 2023
Accepted: November 2, 2023
Article in press: November 2, 2023
Published online: November 16, 2023
Processing time: 51 Days and 20.6 Hours
ARTICLE HIGHLIGHTS
Research background

The optimal timing and dose of aspirin initiation after an acute stroke are still debated. This study aimed to evaluate the efficacy and safety of aspirin antiplatelet therapy within 48 h of symptom onset in patients with acute stroke. A randomized controlled trial was conducted. The primary outcome was the occurrence of recurrent stroke, myocardial infarction, or vascular death within 90 d. Secondary outcomes comprised functional outcomes, bleeding complications, and mortality rates. Results showed favorable functional outcomes with aspirin use, but no significant reduction in recurrent vascular events. Larger studies with longer follow-up periods are needed for further confirmation.

Research motivation

The optimal timing and dose of aspirin initiation after acute stroke are still debated, highlighting the need for further investigation. This study aimed to evaluate the efficacy and safety of aspirin antiplatelet therapy within 48 h of symptom onset in patients with acute stroke. Understanding the impact of aspirin use on functional outcomes and recurrent vascular events is crucial for informing clinical decision-making and optimizing patient care. Larger studies with longer follow-up periods will provide more conclusive evidence in this field and guide future management strategies for acute stroke patients.

Research objectives

The primary aim was to assess the occurrence of recurrent stroke, myocardial infarction, or vascular death within 90 days. Secondary objectives included evaluating functional outcomes at 90 d using the modified Rankin Scale, determining the incidence of bleeding complications, and comparing mortality rates between the aspirin and no aspirin groups. By addressing these objectives, the study aimed to provide valuable insights into the use of aspirin in acute stroke management.

Research methods

A randomized, open-label, controlled trial was conducted involving 60 patients with acute ischemic or hemorrhagic stroke admitted within 24 h of symptom onset. Patients were randomly assigned to receive either a daily dose of 300 mg aspirin or no aspirin within 48 h of stroke onset. The primary outcome measured was the occurrence of recurrent stroke, myocardial infarction, or vascular death within 90 d. Secondary outcomes included functional outcomes at 90 d using the modified Rankin Scale (mRS), the incidence of bleeding complications, and mortality rate. Baseline characteristics were balanced between the two groups, and statistical analyses were performed to assess the relative risk and significance of the outcomes.

Research results

Among the 60 patients included, those in the aspirin group showed favorable functional outcomes compared to the no aspirin group, as indicated by significantly lower modified Rankin Scale (mRS) scores at 90 d. However, there was no significant reduction in the occurrence of recurrent stroke, myocardial infarction, or vascular death between the two groups. The incidence of bleeding complications and mortality rates were comparable between the aspirin and no aspirin groups. Further studies with larger sample sizes and longer follow-up periods are necessary to validate these findings.

Research conclusions

Aspirin use within 48 h of symptom onset in acute stroke patients is associated with improved functional outcomes. However, there is no significant reduction in the risk of recurrent stroke, myocardial infarction, or vascular death compared to not using aspirin. The safety profile of aspirin is similar to that of no aspirin in terms of bleeding complications and mortality rates. To validate these results, further research with larger sample sizes and longer follow-up periods is necessary.

Research perspectives

The study results highlight the need for further investigation into the optimal timing and dose of aspirin initiation after acute stroke. Future studies should consider larger sample sizes and longer follow-up periods to confirm the findings regarding functional outcomes and the risk reduction of recurrent vascular events. Additionally, exploring alternative antiplatelet therapies or combination treatments may provide valuable insights into improving outcomes in acute stroke management. Overall, ongoing research is necessary to refine the use of aspirin and optimize its benefits in the context of acute stroke.