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 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, Angel | - |
dc.contributor.author | Choi, Dennis W. | - |
dc.date.available | 2020-02-27T10:41:00Z | - |
dc.date.created | 2020-02-07 | - |
dc.date.issued | 2018-07-13 | - |
dc.identifier.issn | 1745-6215 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/3572 | - |
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.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | BMC | - |
dc.relation.isPartOf | TRIALS | - |
dc.subject | BRAIN-INJURY | - |
dc.subject | THROMBECTOMY | - |
dc.subject | HYPOTHERMIA | - |
dc.subject | ANTAGONIST | - |
dc.subject | DAMAGE | - |
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 | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000438795600003 | - |
dc.identifier.doi | 10.1186/s13063-018-2746-9 | - |
dc.identifier.bibliographicCitation | TRIALS, v.19 | - |
dc.identifier.scopusid | 2-s2.0-85050011336 | - |
dc.citation.title | TRIALS | - |
dc.citation.volume | 19 | - |
dc.contributor.affiliatedAuthor | Lee, Yeong-Bae | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Endovascular recanalization | - |
dc.subject.keywordAuthor | Ischemia and reperfusion | - |
dc.subject.keywordAuthor | Neuroprotectants | - |
dc.subject.keywordAuthor | Collateral | - |
dc.subject.keywordPlus | BRAIN-INJURY | - |
dc.subject.keywordPlus | THROMBECTOMY | - |
dc.subject.keywordPlus | HYPOTHERMIA | - |
dc.subject.keywordPlus | ANTAGONIST | - |
dc.subject.keywordPlus | DAMAGE | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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