Nelonemdaz for Patients With Acute Ischemic Stroke Undergoing Endovascular Reperfusion Therapy: A Randomized Phase II Trial
DC Field | Value | Language |
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dc.contributor.author | Hong, Ji Man | - |
dc.contributor.author | Lee, Jin Soo | - |
dc.contributor.author | Lee, Yeong-Bae | - |
dc.contributor.author | Shin, Dong Hoon | - |
dc.contributor.author | Shin, Dong-Ick | - |
dc.contributor.author | Hwang, Yang-Ha | - |
dc.contributor.author | Ahn, Seong Hwan | - |
dc.contributor.author | Kim, Jae Guk | - |
dc.contributor.author | Sohn, Sung-Il | - |
dc.contributor.author | Kwon, Sun U. | - |
dc.contributor.author | Lee, Ji Sung | - |
dc.contributor.author | Gwag, Byoung Joo | - |
dc.contributor.author | Chamorro, Angel | - |
dc.contributor.author | Choi, Dennis W. | - |
dc.date.accessioned | 2022-12-21T04:40:12Z | - |
dc.date.available | 2022-12-21T04:40:12Z | - |
dc.date.created | 2022-12-12 | - |
dc.date.issued | 2022-11 | - |
dc.identifier.issn | 0039-2499 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/86301 | - |
dc.description.abstract | BACKGROUND: Nelonemdaz is a multitarget neuroprotectant that selectively blocks N-methyl-D-aspartate receptors and scavenges free radicals, as proven in preclinical ischemia-reperfusion studies. We aimed to evaluate the safety and efficacy of nelonemdaz in patients with acute ischemic stroke receiving endovascular reperfusion therapy. METHODS: This phase II randomized trial involved participants with large-artery occlusion in the anterior circulation at baseline who received endovascular reperfusion therapy <8 hours from symptom onset at 7 referral stroke centers in South Korea between October 29, 2016, and June 1, 2020. Two hundred thirteen patients were screened and 209 patients were randomly assigned at a 1:1:1 ratio using a computer-generated randomization system. Patients were divided into 3 groups based on the medication received-placebo, low-dose (2750 mg) nelonemdaz, and high-dose (5250 mg) nelonemdaz. The primary outcome was the proportion of patients with modified Rankin Scale scores of 0-2 at 12 weeks. RESULTS: Two hundred eight patients were assigned to the placebo (n=70), low-dose (n=71), and high-dose (n=67) groups. The groups had similar baseline characteristics. The primary outcome was achieved in 183 patients, and it did not differ among the groups (33/61 [54.1%], 40/65 [61.5%], and 36/57 [63.2%] patients; P=0.5578). The common odds ratio (90% CI) indicating a favorable shift in the modified Rankin Scale scores at 12 weeks was 1.55 (0.92-2.60) between the placebo and low-dose groups and 1.61 (0.94-2.76) between the placebo and high-dose groups. No serious adverse events were reported. CONCLUSIONS: The study arms showed no significant difference in the proportion of patients achieving modified Rankin Scale scores of 0-2 at 12 weeks. Nevertheless, nelonemdaz-treated patients showed a favorable tendency toward achieving these scores at 12 weeks, without serious adverse effects. Thus, a large-scale phase III trial is warranted. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | - |
dc.relation.isPartOf | STROKE | - |
dc.title | Nelonemdaz for Patients With Acute Ischemic Stroke Undergoing Endovascular Reperfusion Therapy: A Randomized Phase II Trial | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000874088700013 | - |
dc.identifier.doi | 10.1161/STROKEAHA.122.039649 | - |
dc.identifier.bibliographicCitation | STROKE, v.53, no.11, pp.3250 - 3259 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.scopusid | 2-s2.0-85140658551 | - |
dc.citation.endPage | 3259 | - |
dc.citation.startPage | 3250 | - |
dc.citation.title | STROKE | - |
dc.citation.volume | 53 | - |
dc.citation.number | 11 | - |
dc.contributor.affiliatedAuthor | Lee, Yeong-Bae | - |
dc.contributor.affiliatedAuthor | Shin, Dong Hoon | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | cerebral infarction | - |
dc.subject.keywordAuthor | ischemic stroke | - |
dc.subject.keywordAuthor | neuroprotective agent | - |
dc.subject.keywordAuthor | odds ratio | - |
dc.subject.keywordAuthor | reperfusion | - |
dc.subject.keywordPlus | INTRAARTERIAL TREATMENT | - |
dc.subject.keywordPlus | NMDA RECEPTOR | - |
dc.subject.keywordPlus | NEU2000 | - |
dc.subject.keywordPlus | THROMBECTOMY | - |
dc.subject.keywordPlus | NXY-059 | - |
dc.subject.keywordPlus | RECANALIZATION | - |
dc.subject.keywordPlus | HYPOTHERMIA | - |
dc.subject.keywordPlus | ANTAGONIST | - |
dc.subject.keywordPlus | TELEPHONE | - |
dc.subject.keywordPlus | PROTOCOL | - |
dc.relation.journalResearchArea | Neurosciences & Neurology | - |
dc.relation.journalResearchArea | Cardiovascular System & Cardiology | - |
dc.relation.journalWebOfScienceCategory | Clinical Neurology | - |
dc.relation.journalWebOfScienceCategory | Peripheral Vascular Disease | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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