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 |
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| creator | 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 |
| description | 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 |
| doi_str_mv | 10.1161/STROKEAHA.120.031197 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmed_primary_33588596</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2490120877</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3522-eaf80169d838eb979788cbb060a667881ff5e10394dcd4012e2831ab9b5ae0273</originalsourceid><addsrcrecordid>eNqNUttu1DAQjRCILoU_QMiPSDSLL7nYvIV0oSsqFbULr5aTTJRQJ97aTpf2K_hknG7ZvvLimdGcM6M5x1H0luAlIRn5eLW5vPi2Ks6KJaF4iRkhIn8WLUhKkzjJKH8eLTBmIqaJEEfRK-d-YYwp4-nL6IixlPNUZIvoz6pRVt2aEdAp_K6MHcFo9BOsmxx66hV6fltjke8AbSwoP8DokWlRUU8e0NrVHQx9ja68NdfwCRXoe6dcaKzXJ-hSjY0Z-ntoTtCpmSoN8Wfdj6EqzbANS3x_O4_tlX4dvWiVdvDmMR5HP76sNuVZfH7xdV0W53HNUkpjUC3HJBMNZxwqkYuc87qqcIZVloWctG0KJNyfNHWTYEKBckZUJapUAaY5O47e7-durbmZwHk59K4GrVVQYHIyyBZYmOczNNlDa2ucs9DKre0HZe8kwXL2Qh68kIEi914E2rvHDVM1QHMg_RM_AD7sATuoTOvqHsYaDrDgVsYEI2keMjyP4_-PLnsfNDVjaabRPx2wM9oHa6_1tAMrO1Dad_KBkOU4ppgGxUIV44ev8he3Q7Wk</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2490120877</pqid></control><display><type>article</type><title>Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial</title><source>American Heart Association Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Journals@Ovid Complete</source><source>Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></source><source>Alma/SFX Local Collection</source><creator>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</creator><creatorcontrib>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 ; TASTE Trial Investigators</creatorcontrib><description>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: . Unique identifier: NCT02430350.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/STROKEAHA.120.031197</identifier><identifier>PMID: 33588596</identifier><language>eng</language><publisher>PHILADELPHIA: Lippincott Williams & Wilkins</publisher><subject>Cardiovascular System & Cardiology ; Clinical Neurology ; Life Sciences & Biomedicine ; Neurosciences & Neurology ; Peripheral Vascular Disease ; Science & Technology</subject><ispartof>Stroke (1970), 2021-03, Vol.52 (3), p.772-780</ispartof><rights>Lippincott Williams & Wilkins</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>108</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000639315700007</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c3522-eaf80169d838eb979788cbb060a667881ff5e10394dcd4012e2831ab9b5ae0273</citedby><cites>FETCH-LOGICAL-c3522-eaf80169d838eb979788cbb060a667881ff5e10394dcd4012e2831ab9b5ae0273</cites><orcidid>0000-0002-7486-1992 ; 0000-0003-4351-2877 ; 0000-0003-3154-0985 ; 0000-0002-8034-9477 ; 0000-0003-2725-2788 ; 0000-0001-8345-5147 ; 0000-0002-9976-2341 ; 0000-0002-7263-0365</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,3689,27931,27932,39265</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33588596$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Xu, Jie</creatorcontrib><creatorcontrib>Wang, Anxin</creatorcontrib><creatorcontrib>Meng, Xia</creatorcontrib><creatorcontrib>Yalkun, Gulbahram</creatorcontrib><creatorcontrib>Xu, Anding</creatorcontrib><creatorcontrib>Gao, Zhiqiang</creatorcontrib><creatorcontrib>Chen, Huisheng</creatorcontrib><creatorcontrib>Ji, Yong</creatorcontrib><creatorcontrib>Xu, Jun</creatorcontrib><creatorcontrib>Geng, Deqin</creatorcontrib><creatorcontrib>Zhu, Runxiu</creatorcontrib><creatorcontrib>Liu, Bo</creatorcontrib><creatorcontrib>Dong, Aiqin</creatorcontrib><creatorcontrib>Mu, Hua</creatorcontrib><creatorcontrib>Lu, Zhihong</creatorcontrib><creatorcontrib>Li, Shuya</creatorcontrib><creatorcontrib>Zheng, Huaguang</creatorcontrib><creatorcontrib>Chen, Xia</creatorcontrib><creatorcontrib>Wang, Yilong</creatorcontrib><creatorcontrib>Zhao, Xingquan</creatorcontrib><creatorcontrib>Wang, Yongjun</creatorcontrib><creatorcontrib>TASTE Trial Investigators</creatorcontrib><title>Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial</title><title>Stroke (1970)</title><addtitle>STROKE</addtitle><addtitle>Stroke</addtitle><description>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: . Unique identifier: NCT02430350.</description><subject>Cardiovascular System & Cardiology</subject><subject>Clinical Neurology</subject><subject>Life Sciences & Biomedicine</subject><subject>Neurosciences & Neurology</subject><subject>Peripheral Vascular Disease</subject><subject>Science & Technology</subject><issn>0039-2499</issn><issn>1524-4628</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><recordid>eNqNUttu1DAQjRCILoU_QMiPSDSLL7nYvIV0oSsqFbULr5aTTJRQJ97aTpf2K_hknG7ZvvLimdGcM6M5x1H0luAlIRn5eLW5vPi2Ks6KJaF4iRkhIn8WLUhKkzjJKH8eLTBmIqaJEEfRK-d-YYwp4-nL6IixlPNUZIvoz6pRVt2aEdAp_K6MHcFo9BOsmxx66hV6fltjke8AbSwoP8DokWlRUU8e0NrVHQx9ja68NdfwCRXoe6dcaKzXJ-hSjY0Z-ntoTtCpmSoN8Wfdj6EqzbANS3x_O4_tlX4dvWiVdvDmMR5HP76sNuVZfH7xdV0W53HNUkpjUC3HJBMNZxwqkYuc87qqcIZVloWctG0KJNyfNHWTYEKBckZUJapUAaY5O47e7-durbmZwHk59K4GrVVQYHIyyBZYmOczNNlDa2ucs9DKre0HZe8kwXL2Qh68kIEi914E2rvHDVM1QHMg_RM_AD7sATuoTOvqHsYaDrDgVsYEI2keMjyP4_-PLnsfNDVjaabRPx2wM9oHa6_1tAMrO1Dad_KBkOU4ppgGxUIV44ev8he3Q7Wk</recordid><startdate>20210301</startdate><enddate>20210301</enddate><creator>Xu, Jie</creator><creator>Wang, Anxin</creator><creator>Meng, Xia</creator><creator>Yalkun, Gulbahram</creator><creator>Xu, Anding</creator><creator>Gao, Zhiqiang</creator><creator>Chen, Huisheng</creator><creator>Ji, Yong</creator><creator>Xu, Jun</creator><creator>Geng, Deqin</creator><creator>Zhu, Runxiu</creator><creator>Liu, Bo</creator><creator>Dong, Aiqin</creator><creator>Mu, Hua</creator><creator>Lu, Zhihong</creator><creator>Li, Shuya</creator><creator>Zheng, Huaguang</creator><creator>Chen, Xia</creator><creator>Wang, Yilong</creator><creator>Zhao, Xingquan</creator><creator>Wang, Yongjun</creator><general>Lippincott Williams & Wilkins</general><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7486-1992</orcidid><orcidid>https://orcid.org/0000-0003-4351-2877</orcidid><orcidid>https://orcid.org/0000-0003-3154-0985</orcidid><orcidid>https://orcid.org/0000-0002-8034-9477</orcidid><orcidid>https://orcid.org/0000-0003-2725-2788</orcidid><orcidid>https://orcid.org/0000-0001-8345-5147</orcidid><orcidid>https://orcid.org/0000-0002-9976-2341</orcidid><orcidid>https://orcid.org/0000-0002-7263-0365</orcidid></search><sort><creationdate>20210301</creationdate><title>Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3522-eaf80169d838eb979788cbb060a667881ff5e10394dcd4012e2831ab9b5ae0273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Cardiovascular System & Cardiology</topic><topic>Clinical Neurology</topic><topic>Life Sciences & Biomedicine</topic><topic>Neurosciences & Neurology</topic><topic>Peripheral Vascular Disease</topic><topic>Science & Technology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Xu, Jie</creatorcontrib><creatorcontrib>Wang, Anxin</creatorcontrib><creatorcontrib>Meng, Xia</creatorcontrib><creatorcontrib>Yalkun, Gulbahram</creatorcontrib><creatorcontrib>Xu, Anding</creatorcontrib><creatorcontrib>Gao, Zhiqiang</creatorcontrib><creatorcontrib>Chen, Huisheng</creatorcontrib><creatorcontrib>Ji, Yong</creatorcontrib><creatorcontrib>Xu, Jun</creatorcontrib><creatorcontrib>Geng, Deqin</creatorcontrib><creatorcontrib>Zhu, Runxiu</creatorcontrib><creatorcontrib>Liu, Bo</creatorcontrib><creatorcontrib>Dong, Aiqin</creatorcontrib><creatorcontrib>Mu, Hua</creatorcontrib><creatorcontrib>Lu, Zhihong</creatorcontrib><creatorcontrib>Li, Shuya</creatorcontrib><creatorcontrib>Zheng, Huaguang</creatorcontrib><creatorcontrib>Chen, Xia</creatorcontrib><creatorcontrib>Wang, Yilong</creatorcontrib><creatorcontrib>Zhao, Xingquan</creatorcontrib><creatorcontrib>Wang, Yongjun</creatorcontrib><creatorcontrib>TASTE Trial Investigators</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Stroke (1970)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Xu, Jie</au><au>Wang, Anxin</au><au>Meng, Xia</au><au>Yalkun, Gulbahram</au><au>Xu, Anding</au><au>Gao, Zhiqiang</au><au>Chen, Huisheng</au><au>Ji, Yong</au><au>Xu, Jun</au><au>Geng, Deqin</au><au>Zhu, Runxiu</au><au>Liu, Bo</au><au>Dong, Aiqin</au><au>Mu, Hua</au><au>Lu, Zhihong</au><au>Li, Shuya</au><au>Zheng, Huaguang</au><au>Chen, Xia</au><au>Wang, Yilong</au><au>Zhao, Xingquan</au><au>Wang, Yongjun</au><aucorp>TASTE Trial Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial</atitle><jtitle>Stroke (1970)</jtitle><stitle>STROKE</stitle><addtitle>Stroke</addtitle><date>2021-03-01</date><risdate>2021</risdate><volume>52</volume><issue>3</issue><spage>772</spage><epage>780</epage><pages>772-780</pages><issn>0039-2499</issn><eissn>1524-4628</eissn><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: . Unique identifier: NCT02430350.</abstract><cop>PHILADELPHIA</cop><pub>Lippincott Williams & Wilkins</pub><pmid>33588596</pmid><doi>10.1161/STROKEAHA.120.031197</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-7486-1992</orcidid><orcidid>https://orcid.org/0000-0003-4351-2877</orcidid><orcidid>https://orcid.org/0000-0003-3154-0985</orcidid><orcidid>https://orcid.org/0000-0002-8034-9477</orcidid><orcidid>https://orcid.org/0000-0003-2725-2788</orcidid><orcidid>https://orcid.org/0000-0001-8345-5147</orcidid><orcidid>https://orcid.org/0000-0002-9976-2341</orcidid><orcidid>https://orcid.org/0000-0002-7263-0365</orcidid></addata></record> |
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| ispartof | Stroke (1970), 2021-03, Vol.52 (3), p.772-780 |
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| language | eng |
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| source | American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Journals@Ovid Complete; Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" />; Alma/SFX Local Collection |
| subjects | Cardiovascular System & Cardiology Clinical Neurology Life Sciences & Biomedicine Neurosciences & Neurology Peripheral Vascular Disease Science & Technology |
| title | Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial |
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