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Chen, Hui-Sheng, Cui, Yu, Wang, Xin-Hong, Ma, Yu-Tong, Han, Jing, Duan, Ying-Jie, Lu, Jiang, Shen, Li-Ying, Liang, Yong, Wang, Wei-Zhong, Wang, Hui, Zhao, Yong, Zhang, Jin-Tao, Song, Yu-Lin, He, Xiao-Mei, Li, Run-Hui, Tao, Ding-Bo, Li, Jing, Huang, Shu-Man, Wang, Ni, Hong, Mei, Meng, Chong, Zhang, Wei, Wang, Duolao 
ORCID: https://orcid.org/0000-0003-2788-2464, Nguyen, Thanh N., Chen, Shao-Yuan, Zhao, Li-Hong, Xiao, Hong-Bo, Han, Bing, Hai, Ying, He, Zhong-Lian, Zhang, Li-Yang, Wang, Lian-Qiang, Pan, Ping-Kang, Li, Dong-Qun, Zhang, Yu-Tao, Wang, Dong-Yu, Li, Jing-Yu, Zhang, Hong-Li, Qiu, Xiao-Feng, Bai, Fu-Sheng, Gong, Xu-Hai, Xu, Jun, Song, Cheng-Guang, Yuan, Zhi-Mei, Du, Yan, Zhang, Ping, Sheng, Bao-Ying, Ju, Xiao-Hua, Zhu, Xin-Chen, Song, Xiao-Hong, Liu, Ya-Jun, Guo, Yan-Qin, Chen, Hui-Ru, Lin, Yong-Zhong, Xue, Wei-Shu, Meng, Zhao-Min, Jiang, Li-Yan, Zhang, Qing-Hua, Liu, Hui-Min, Xu, Zhong-Xin, Liu, Chuan-Yu, Zou, Ren-Lin, Zhao, Chun-Gang, Li, Hui, Zhang, Shuang-Yan, Wang, Zeng-Bao, Wei, Ya-Fen, Qiu, Xue-Rong and Jiang, Chang-Hao
(2024)
'Clopidogrel Plus Aspirin vs Aspirin Alone in Patients With Acute Mild to Moderate Stroke'. JAMA Neurology.
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Clopidogrel Plus Aspirin vs Aspirin Alone_JAMA Neurology 2024.pdf - Accepted Version Download (381kB) | Preview |
Abstract
Importance
Dual antiplatelet therapy has been demonstrated to be superior to single antiplatelet in reducing recurrent stroke among patients with transient ischemic attack or minor stroke, but robust evidence for its effect in patients with mild to moderate ischemic stroke is lacking.
Objective
To evaluate whether dual antiplatelet therapy is superior to single antiplatelet among patients with mild to moderate ischemic stroke.
Design, Setting, and Participants
This was a multicenter, open-label, blinded end point, randomized clinical trial conducted at 66 hospitals in China from December 20, 2016, through August 9, 2022. The date of final follow-up was October 30, 2022. The analysis was reported on March 12, 2023. Of 3065 patients with ischemic stroke, 3000 patients with acute mild to moderate stroke within 48 hours of symptom onset were enrolled, after excluding 65 patients who did not meet eligibility criteria or had no randomization outcome.
Interventions
Within 48 hours after symptom onset, patients were randomly assigned to receive clopidogrel plus aspirin (n = 1541) or aspirin alone (n = 1459) in a 1:1 ratio.
Main Outcomes and Measures
The primary end point was early neurologic deterioration at 7 days, defined as an increase of 2 or more points in National Institutes of Health Stroke Scale (NIHSS) score, but not as a result of cerebral hemorrhage, compared with baseline. The superiority of clopidogrel plus aspirin to aspirin alone was assessed based on a modified intention-to-treat population, which included all randomized participants with at least 1 efficacy evaluation regardless of treatment allocation. Bleeding events were safety end points.
Results
Of the 3000 randomized patients, 1942 (64.6%) were men, the mean (SD) age was 65.9 (10.6) years, median (IQR) NIHSS score at admission was 5 (4-6), and 1830 (61.0%) had a stroke of undetermined cause. A total of 2915 patients were included in the modified intention-to-treat analysis. Early neurologic deterioration occurred in 72 of 1502 (4.8%) in the dual antiplatelet therapy group vs 95 of 1413 (6.7%) in the aspirin alone group (risk difference −1.9%; 95% CI, −3.6 to −0.2; P = .03). Similar bleeding events were found between 2 groups.
Conclusions and Relevance
Among Chinese patients with acute mild to moderate ischemic stroke, clopidogrel plus aspirin was superior to aspirin alone with regard to reducing early neurologic deterioration at 7 days with similar safety profile. These findings indicate that dual antiplatelet therapy may be a superior choice to aspirin alone in treating patients with acute mild to moderate stroke.Trial RegistrationClinicalTrials.gov Identifier: NCT02869009
| Item Type: | Article |
|---|---|
| Subjects: | QV Pharmacology > Central Nervous System Agents. Local Anesthetics > QV 95 Anti-inflammatory analgesics. Non-narcotic analgesics WL Nervous System > WL 20 Research (General) |
| Faculty: Department: | Clinical Sciences & International Health > Clinical Sciences Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1001/jamaneurol.2024.0146 |
| SWORD Depositor: | JISC Pubrouter |
| Depositing User: | JISC Pubrouter |
| Date Deposited: | 21 Mar 2024 13:16 |
| Last Modified: | 21 Mar 2024 13:18 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/24226 |
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