Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): study protocol for a randomized controlled trial

BMC Neurology

Pingyan Chen¹  Guoshuai Yang²  Guohu Weng³  Yunqiang Huang⁴  Guangning Li⁵  Wenguo Huang⁶  Zhi Yang⁷  Suyue Pan⁸  Yongming Wu⁸  Kaibin Huang⁸  Zhong Ji⁸  Saijun Zhou⁹ 

[1] Department of Biostatistics, School of Public Health, Southern Medical University;Department of Neurology, Haikou People’s Hospital;Department of Neurology, Hainan Hospital of Traditional Chinese Medicine;Department of Neurology, Heyuan People’s Hospital;Department of Neurology, Huadu district People’s Hospital;Department of Neurology, Maoming Hospital of Traditional Chinese Medicine;Department of Neurology, Maoming People’s Hospital;Department of Neurology, Nanfang Hospital, Southern Medical University;Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University;

关键词: Combined treatment;    Glibenclamide;    Randomized controlled trial;    Stroke;   

DOI  :  10.1186/s12883-020-01823-z

来源: DOAJ

【 摘 要 】

Abstract Background Thrombolysis with recombinant tissue plasminogen activator (rtPA) improves outcome for patients with acute ischemic stroke (AIS), but many of them still have substantial disability. Glibenclamide (US adopted name, glyburide), a long-acting sulfonylurea, shows promising result in treating AIS from both preclinical and clinical studies. This study investigates the safety and efficacy of glibenclamide combined with rtPA in treating AIS patients. Methods This is a prospective, randomized, double-blind, placebo-controlled, multicenter trial with an estimated sample size of 306 cases, starting in January 2018. Patients aged 18 to 74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4 to 25 points and treated with intravenous rtPA within the first 4.5 h of their clinical onsets, are eligible for participation in this study. The target time from the onset of symptoms to receive the study drug is of 10 h. Subjects are randomized 1: 1 to receive glibenclamide or placebo with a loading dose of 1.25 mg, followed by 0.625 mg every 8 h for total 5 days. The primary efficacy endpoint is 90-day good outcome, measured as modified Rankin Scale of 0 to 2. Safety outcomes are all-cause 30-day mortality and early neurological deterioration, with a focus on cardiac- and glucose-related serious adverse events. Discussion This study will provide valuable information about the safety and efficacy of oral glibenclamide for AIS patients treated with rtPA. This would bring benefits to a large number of patients if the agent is proved to be effective. Trial registration The trial was registered on September 14th 2017 at www.clinicaltrials.gov having identifier NCT03284463 . Registration was performed before recruitment was initiated.

【 授权许可】

Unknown