Clinical Trial

. 2021 Mar;52(3):772-780.

doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.

Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial

Jie Xu^#^{1

2}, Anxin Wang^#^{1

2}, Xia Meng^#^{1

2}, Gulbahram Yalkun^{1

2}, Anding Xu³, Zhiqiang Gao⁴, Huisheng Chen⁵, Yong Ji⁶, Jun Xu⁷, Deqin Geng⁸, Runxiu Zhu⁹, Bo Liu¹⁰, Aiqin Dong¹¹, Hua Mu¹², Zhihong Lu¹², Shuya Li^{1

2}, Huaguang Zheng^{1

2}, Xia Chen^{1

2}, Yilong Wang^{1

2}, Xingquan Zhao^{1

2}, Yongjun Wang¹; TASTE Trial Investigators†

Collaborators, Affiliations

Collaborators

TASTE Trial Investigators†:
Yongjun Wang, Anding Xu, Xingquan Zhao, Xia Chen, Yongjun Wang, Xia Meng, Yilong Wang, Jie Xu, Anxin Wang, Huaguang Zheng, Zhiqiang Gao, Lei Duan, Jinghua Zhang, Shuya Li, Donghua Lou, Zhiqiang Gao, Huisheng Chen, Yong Ji, Jun Xu, Deqin Geng, Runxiu Zhu, Bo Liu, Aiqin Dong, Qingcheng Liang, Hong Yang, Cunju Guo, Xin Li, Mingli He, Xiangyang Tian, Yong Cui, Junshan Zhou, Ning Wang, Lei Wang, Xinjiang Zhang, Xiaoping Gao, Liping Lu, Tong Li, Yan Cheng, Kaixiang Liu, Xiaokun Xi, Baojun Wang, Lin Sun, Shigang Zhao, Xiaofan Chu, Yajun Lian, Fuling Yan, Xiaoshan Wang, Dong Wang, Bei Shao, Jinsong Jiao, Heng Wu, Guanglai Li, Libin Guo, Yongjun Wang, Suyue Pan, Anding Xu, Heng Li, Jianhua Zhuang, Xin Li, Jun Wu, Anxin Wang, Donghua Lou, Yingting Zuo, Yijun Zhang, Xiaoli Zhang, Xiaofei Feng, Xia Meng, David Wang, Kehui Dong, Yanfang Liu, Hao Li, Dawei Chen, Qiushi Lv

Affiliations

¹ Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).
² China National Clinical Research Center for Neurological Diseases, Beijing (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).
³ Department of Neurology and Stroke Center, The First Affiliated Hospital of Jinan University, Guangzhou, China (A.X.).
⁴ Department of Neurology, The Second Affiliated Hospital of Nanjing Medical University, China (Z.G.).
⁵ Department of Neurology, The General Hospital of Shenyang Military, China (H.C.).
⁶ Department of Neurology, Tianjin Huanhu Hospital, China (Y.J.).
⁷ Department of Neurology, Subei People's Hospital of Jiangsu Province, Yangzhou, China (Jun Xu).
⁸ Department of Neurology, The Affiliated Hospital of Xuzhou Medical University, China (D.G.).
⁹ Department of Neurology, Inner Mongolia Autonomous Region People's Hospital, Hohhot, China (R.Z.).
¹⁰ Department of Neurology, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, China (B.L.).
¹¹ Department of Neurology, Cangzhou Central Hospital, China (A.D.).
¹² State Key Laboratory of Translational Medicine and Innovative Drug Development, Nanjing, China (H.M., Z.L.).

^# Contributed equally.

PMID: 33588596
DOI: 10.1161/STROKEAHA.120.031197

Clinical Trial

Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial

Jie Xu et al. Stroke. 2021 Mar.

. 2021 Mar;52(3):772-780.

doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.

Authors

Collaborators

TASTE Trial Investigators†:
Yongjun Wang, Anding Xu, Xingquan Zhao, Xia Chen, Yongjun Wang, Xia Meng, Yilong Wang, Jie Xu, Anxin Wang, Huaguang Zheng, Zhiqiang Gao, Lei Duan, Jinghua Zhang, Shuya Li, Donghua Lou, Zhiqiang Gao, Huisheng Chen, Yong Ji, Jun Xu, Deqin Geng, Runxiu Zhu, Bo Liu, Aiqin Dong, Qingcheng Liang, Hong Yang, Cunju Guo, Xin Li, Mingli He, Xiangyang Tian, Yong Cui, Junshan Zhou, Ning Wang, Lei Wang, Xinjiang Zhang, Xiaoping Gao, Liping Lu, Tong Li, Yan Cheng, Kaixiang Liu, Xiaokun Xi, Baojun Wang, Lin Sun, Shigang Zhao, Xiaofan Chu, Yajun Lian, Fuling Yan, Xiaoshan Wang, Dong Wang, Bei Shao, Jinsong Jiao, Heng Wu, Guanglai Li, Libin Guo, Yongjun Wang, Suyue Pan, Anding Xu, Heng Li, Jianhua Zhuang, Xin Li, Jun Wu, Anxin Wang, Donghua Lou, Yingting Zuo, Yijun Zhang, Xiaoli Zhang, Xiaofei Feng, Xia Meng, David Wang, Kehui Dong, Yanfang Liu, Hao Li, Dawei Chen, Qiushi Lv

Affiliations

¹ Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).
² China National Clinical Research Center for Neurological Diseases, Beijing (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).
³ Department of Neurology and Stroke Center, The First Affiliated Hospital of Jinan University, Guangzhou, China (A.X.).
⁴ Department of Neurology, The Second Affiliated Hospital of Nanjing Medical University, China (Z.G.).
⁵ Department of Neurology, The General Hospital of Shenyang Military, China (H.C.).
⁶ Department of Neurology, Tianjin Huanhu Hospital, China (Y.J.).
⁷ Department of Neurology, Subei People's Hospital of Jiangsu Province, Yangzhou, China (Jun Xu).
⁸ Department of Neurology, The Affiliated Hospital of Xuzhou Medical University, China (D.G.).
⁹ Department of Neurology, Inner Mongolia Autonomous Region People's Hospital, Hohhot, China (R.Z.).
¹⁰ Department of Neurology, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, China (B.L.).
¹¹ Department of Neurology, Cangzhou Central Hospital, China (A.D.).
¹² State Key Laboratory of Translational Medicine and Innovative Drug Development, Nanjing, China (H.M., Z.L.).

^# Contributed equally.

PMID: 33588596
DOI: 10.1161/STROKEAHA.120.031197

Abstract

Background and purpose: Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The present clinical trial aimed at testing the effects of edaravone dexborneol versus edaravone on 90-day functional outcome in patients with acute ischemic stroke (AIS).

Methods: A multicenter, randomized, double-blind, comparative, phase III clinical trial was conducted at 48 hospitals in China between May 2015 and December 2016. Inclusion criteria included patients diagnosed as AIS, 35 to 80 years of age, National Institutes of Health Stroke Scale Score between 4 and 24, and within 48 hours of AIS onset. AIS patients were randomized in 1:1 ratio into 2 treatment arms: 14-day infusion of edaravone dexborneol or edaravone injection. The primary end point was the proportion of patients with modified Rankin Scale score ≤1 on day 90 after randomization.

Results: One thousand one hundred sixty-five AIS patients were randomly allocated to the edaravone dexborneol group (n=585) or the edaravone group (n=580). The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12-1.81]; P=0.004). The prespecified subgroup analyses indicated that a greater benefit was observed in female patients than their male counterparts (2.26, 1.49-3.43 versus 1.14, 0.85-1.52).

Conclusions: When edaravone dexborneol versus edaravone was administered within 48 hours after AIS, 90-day good functional outcomes favored the edaravone dexborneol group, especially in female patients. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02430350.

Keywords: antioxidants; edaravone; ischemic stroke; neuroprotective agents.

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Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial

Collaborators

Affiliations

Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial

Authors

Collaborators

Affiliations

Abstract

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical