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DC Field | Value | Language |
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dc.contributor.author | Hong, Ji Man | - |
dc.contributor.author | Choi, Mun Hee | - |
dc.contributor.author | Sohn, Sung-Il | - |
dc.contributor.author | Hwang, Yang-Ha | - |
dc.contributor.author | Ahn, Seong Hwan | - |
dc.contributor.author | Lee, Yeong-Bae | - |
dc.contributor.author | Shin, Dong-Ick | - |
dc.contributor.author | Chamorro Sánchez, Ángel | - |
dc.contributor.author | Choi, Dennis W. | - |
dc.contributor.author | SONIC investigators | - |
dc.date.accessioned | 2019-06-07T12:57:15Z | - |
dc.date.available | 2019-06-07T12:57:15Z | - |
dc.date.issued | 2018-07-13 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | http://hdl.handle.net/2445/134782 | - |
dc.description.abstract | BACKGROUND: The potential of neuroprotective agents should be revisited in the era of endovascular thrombectomy (EVT) for acute large-artery occlusion because their preclinical effects have been optimized for ischemia and reperfusion injury. Neu2000, a derivative of sulfasalazine, is a multi-target neuroprotectant. It selectively blocks N-methyl-D-aspartate receptors and scavenges for free radicals. This trial aimed to determine whether neuroprotectant administration before EVT is safe and leads to a more favorable outcome. METHODS: This trial is a phase-II, multicenter, three-arm, randomized, double-blinded, placebo-controlled, blinded-endpoint drug trial that enrolled participants aged ≥ 19 years undergoing an EVT attempt less than 8 h from symptom onset, with baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 8, Alberta Stroke Program Early CT score ≥ 6, evidence of large-artery occlusion, and at least moderate collaterals on computed tomography angiography. EVT-attempted patients are randomized into control, low-dose (2.75 g), and high-dose (5.25 g) Neu2000KWL over 5 days. Seventy participants per group are enrolled for 90% power, assuming that the treatment group has a 28.4% higher proportion of participants with functional independence than the placebo group. The primary outcome, based on intention-to-treat criteria is the improvement of modified Rankin Scale (mRS) scores at 3 months using a dichotomized model. Safety outcomes include symptomatic intracranial hemorrhage within 5 days. Secondary outcomes are distributional change of mRS, mean differences in NIHSS score, proportion of NIHSS score 0-2, and Barthel Index > 90 at 1 and 4 weeks, and 3 months. DISCUSSION: The trial results may provide information on new therapeutic options as multi-target neuroprotection might mitigate reperfusion injury in patients with acute ischemic stroke before EVT. | - |
dc.format.extent | 7 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | BioMed Central | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1186/s13063-018-2746-9 | - |
dc.relation.ispartof | Trials, 2018, vol. 19, num. 1, p. 375 | - |
dc.relation.uri | https://doi.org/10.1186/s13063-018-2746-9 | - |
dc.rights | cc-by (c) Hong, Ji Man et al., 2018 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es | - |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | Isquèmia cerebral | - |
dc.subject.classification | Malalties cerebrovasculars | - |
dc.subject.other | Cerebral ischemia | - |
dc.subject.other | Cerebrovascular disease | - |
dc.title | Safety and optimal neuroprotection of neu2000 in acute ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 689713 | - |
dc.date.updated | 2019-06-07T12:57:15Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 30005644 | - |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) Articles publicats en revistes (Medicina) |
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