Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial.

Xiao-fei YU; Xu-ying Zhu; Can-xing Yuan; Dan-hong WU; Yu-wu Zhao; Jia-jun Yang; Chang-de Wang; Wei-wen WU; Xue-yuan Liu; Zhen-guo Liu; Zhi-yu Nie; Ben-qiang Deng; Huan Bao; Long-xuan LI; Chun-yan Wang; Hong-zhi Zhang; Jing-si Zhang; Ji-han Huang; Fan Gong; Ming-zhe Wang; Yong-mei Guo; Yan Sun; Ding-fang Cai

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Naoxintong Capsule for Secondary Prevention of Ischemic Stroke: A Multicenter, Randomized, and Placebo-Controlled Trial.

Author: Xiao-Fei YU ¹ ; Xu-Ying ZHU ¹ ; Can-Xing YUAN ² ; Dan-Hong WU ³ ; Yu-Wu ZHAO ⁴ ; Jia-Jun YANG ⁵ ; Chang-de WANG ⁶ ; Wei-Wen WU ⁷ ; Xue-Yuan LIU ⁸ ; Zhen-Guo LIU ⁹ ; Zhi-Yu NIE ¹⁰ ; Ben-Qiang DENG ¹¹ ; Huan BAO ¹² ; Long-Xuan LI ¹³ ; Chun-Yan WANG ¹⁴ ; Hong-Zhi ZHANG ¹ ; Jing-Si ZHANG ¹ ; Ji-Han HUANG ¹⁵ ; Fan GONG ¹ ; Ming-Zhe WANG ¹ ; Yong-Mei GUO ¹ ; Yan SUN ¹ ; Ding-Fang CAI ¹⁶
Author Information

1. Department of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
2. Department of Neurology, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.
3. Department of Neurology, Shanghai Third People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, 201900, China.
4. Department of Neurology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China.
5. Department of Neurology, Shanghai Sixth People's Hospital East Branch, Shanghai, 201306, China.
6. Department of Neurology, Shanghai TCM-Integrated Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200083, China.
7. Department of Neurology, Zhongshan Hospital Qingpu Branch Affiliated to Fudan University, Shanghai, 201799, China.
8. Department of Neurology, Shanghai Tenth People's Hospital Affiliated to Tongji University, Shanghai, 200072, China.
9. Department of Neurology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.
10. Department of Neurology, Shanghai Tongji Hospital Affiliated to Tongji University, Shanghai, 200065, China.
11. Department of Neurology, Changhai Hospital, Shanghai, 200433, China.
12. Department of Neurology, Orient Hospital Affiliated to Tongji University, Shanghai, 200120, China.
13. Department of Neurology, Shanghai Pudong New Area Gongli Hospital, Shanghai, 200135, China.
14. Department of Neurology, Shanghai Yangpu Hospital of Traditional Chinese Medicine, Shanghai, 200090, China.
15. Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
16. Department of Neurology, and Institute of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. dingfangcai@163.com.
Publication Type:Journal Article
Keywords: Chinese medicine; Naoxintong Capsule; ischemic stroke; randomized controlled trial; secondary prevention
MeSH: Adult; Humans; Secondary Prevention/methods*; Ischemic Stroke; Stroke/prevention & control*; Cerebral Hemorrhage/complications*; Double-Blind Method; Platelet Aggregation Inhibitors
From: Chinese journal of integrative medicine 2022;28(12):1063-1071
CountryChina
Language:English
Abstract: OBJECTIVE:To examine whether the combination of Naoxintong Capsule with standard care could further reduce the recurrence of ischemic stroke without increasing the risk of severe bleeding.
METHODS:A total of 23 Chinese medical centers participated in this trial. Adult patients with a history of ischemic stroke were randomly assigned in a 1:1 ratio using a block design to receive either Naoxintong Capsule (1.2 g orally, twice a day) or placebo in addition to standard care. The primary endpoint was recurrence of ischemic stroke within 2 years. Secondary outcomes included myocardial infarction, death due to recurrent ischemic stroke, and all-cause mortality. The safety of drugs was monitored. Results were analyzed using the intention-to-treat principle.
RESULTS:A total of 2,200 patients were enrolled from March 2015 to March 2016, of whom 143 and 158 in the Naoxintong and placebo groups were lost to follow-up, respectively. Compared with the placebo group, the recurrence rate of ischemic stroke within 2 years was significantly lower in the Naoxintong group [6.5% vs. 9.5%, hazard ratio (HR): 0.665, 95% confidence interval (CI): 0.492-0.899, P=0.008]. The two groups showed no significant differences in the secondary outcomes and safety, including rates of severe hemorrhage, cerebral hemorrhage and subarachnoid hemorrhage (P>0.05).
CONCLUSION:The combination of Naoxintong Capsule with standard care reduced the 2-year stroke recurrence rate in patients with ischemic stroke without increasing the risk of severe hemorrhage in high-risk patients. (Trial registration No. NCT02334969).