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
Abstract
BACKGROUND

Aspirin is a widely used antiplatelet agent that reduces the risk of recurrent ischemic stroke and other vascular events. However, the optimal timing and dose of aspirin initiation after an acute stroke remain controversial.

AIM

To evaluate the efficacy and safety of aspirin antiplatelet therapy within 48 h of symptom onset in patients with acute stroke.

METHODS

We conducted a randomized, open-label, controlled trial in 60 patients with acute ischemic or hemorrhagic stroke who were admitted to our hospital within 24 h of symptom onset. Patients were randomly assigned to receive either aspirin 300 mg daily or no aspirin within 48 h of stroke onset. The primary outcome was the occurrence of recurrent stroke, myocardial infarction, or vascular death within 90 d. The secondary outcomes were functional outcomes at 90 d measured using the modified Rankin Scale (mRS), incidence of bleeding complications, and mortality rate.

RESULTS

The mean age of the patients was 67.8 years and 55% of them were male. The median time from stroke onset to randomization was 12 h. The baseline characteristics were well balanced between the two groups. The primary outcome occurred in 6.7% of patients in the aspirin group and 16.7% of patients in the no aspirin group (relative risk = 0.40, 95% confidence interval: 0.12-1.31, P = 0.13). The mRS score at 90 d was significantly lower in the aspirin group than in the no aspirin group (median, 2 vs 3, respectively; P = 0.04). The incidence of bleeding complications was similar between the groups (6.7% vs 6.7%, P = 1.00). The mortality rates were also comparable between the two groups (10% vs 13.3%, P = 0.69).

CONCLUSION

Aspirin use is associated with favorable functional outcomes but does not significantly reduce the risk of recurrent vascular events. Its acceptable safety profile is comparable to that of no aspirin. Further studies with larger sample sizes and longer follow-up periods are needed to confirm these findings.

Keywords: Aspirin; Acute stroke; Antiplatelet therapy; Recurrent stroke; Recurrent vascular events; Myocardial infarction

Core Tip: While aspirin use within 48 h of acute stroke showed improved functional outcomes, it did not significantly reduce the risk of recurrent vascular events compared to no aspirin. The safety profile of aspirin was acceptable and comparable to no aspirin. Further research with larger sample sizes and longer follow-up is required to validate these findings and determine the optimal timing and dose of aspirin initiation after an acute stroke.