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

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 e...

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Veröffentlicht in:Stroke (1970) 2021-03, Vol.52 (3), p.772-780
Hauptverfasser: Xu, Jie, Wang, Anxin, Meng, Xia, Yalkun, Gulbahram, Xu, Anding, Gao, Zhiqiang, Chen, Huisheng, Ji, Yong, Xu, Jun, Geng, Deqin, Zhu, Runxiu, Liu, Bo, Dong, Aiqin, Mu, Hua, Lu, Zhihong, Li, Shuya, Zheng, Huaguang, Chen, Xia, Wang, Yilong, Zhao, Xingquan, Wang, Yongjun
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Sprache:eng
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Zusammenfassung: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
ISSN:0039-2499
1524-4628
DOI:10.1161/STROKEAHA.120.031197