Nelonemdaz for Patients With Acute Ischemic Stroke Undergoing Endovascular Reperfusion Therapy: A Randomized Phase II Trial

Autor: Ji Man Hong, Jin Soo Lee, Yeong-Bae Lee, Dong Hoon Shin, Dong-Ick Shin, Yang-Ha Hwang, Seong Hwan Ahn, Jae Guk Kim, Sung-Il Sohn, Sun U. Kwon, Ji Sung Lee, Byoung Joo Gwag, Ángel Chamorro, Dennis W. Choi, Ángel Chammorro, Eung Yeop Kim, Jin Wook Choi, Min-Ju Yeo, Jaehyuk Kwak, Sung Eun Lee, Jeong-Ho Hong, Sangkil Lee, Yoon-Joo Lee, Min-Joo Lee
Rok vydání: 2022
Předmět:
Zdroj: Stroke. 53:3250-3259
ISSN: 1524-4628
0039-2499
DOI: 10.1161/strokeaha.122.039649
Popis: 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 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. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT02831088.
Databáze: OpenAIRE
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