POST-UK (Adjunctive Intra-Arterial Urokinase After Successful Endovascular Thrombectomy in Patients With Large-Vessel Occlusion Stroke): Study Protocol of a Multicenter, Prospective, Randomized, Open-Label, Blinded-End Point Trial

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作者
Liu, Chang [1 ,2 ,3 ]
Li, Fengli [2 ,3 ]
Song, Jiaxing [2 ,3 ]
Xu, Xu [2 ,3 ]
Huang, Jiacheng [1 ,2 ,3 ]
Guo, Changwei [2 ,3 ]
Kong, Weilin [2 ,3 ]
Yang, Jie [2 ,3 ]
Shi, Xiaolei [2 ,3 ]
Ma, Jinfu [2 ,3 ]
Yang, Shihai [2 ,3 ]
Wang, Zhixi [2 ,3 ]
Fan, Shitao [2 ,3 ]
Xiang, Liu [2 ,3 ]
Sun, Wenzhe [2 ,3 ]
Yu, Nizhen [2 ,3 ]
Yue, Chengsong [2 ,3 ]
Peng, Zhouzhou [2 ,3 ]
Li, Linyu [2 ,3 ]
Huang, Cheng [2 ,3 ]
Yang, Dahong [2 ,3 ]
Wang, Duolao [4 ]
Saver, Jeffrey [5 ,6 ]
Nguyen, Thanh N. [7 ]
Nogueira, Raul G. [8 ,9 ]
Chen, Yangmei [1 ]
Zi, Wenjie [2 ,3 ]
机构
[1] Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China
[2] Army Med Univ, Third Mil Med Univ, Xinqiao Hosp, Dept Neurol, Chongqing, Peoples R China
[3] Army Med Univ, Third Mil Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China
[4] Univ Liverpool Liverpool Sch Trop Med, Global Hlth Trials Unit, Liverpool, England
[5] Univ Calif Los Angeles, David Geffen Sch Med, Dept Neurol, Los Angeles, CA USA
[6] Univ Calif Los Angeles, Comprehens Stroke Ctr, David Geffen Sch Med, Los Angeles, CA USA
[7] Boston Med Ctr, Dept Neurol & Radiol, Boston, MA USA
[8] Univ Pittsburgh, UPMC Stroke Inst, Sch Med, Dept Neurol, Pittsburgh, PA USA
[9] Univ Pittsburgh, UPMC Stroke Inst, Sch Med, Dept Neurosurg, Pittsburgh, PA USA
来源
基金
中国国家自然科学基金; 中国博士后科学基金;
关键词
adjunctive therapy; endovascular thrombectomy; intra-arterial urokinase; randomized trial; trial protocol; ACUTE ISCHEMIC-STROKE; MECHANICAL THROMBECTOMY; ASSOCIATION GUIDELINES; CLINICAL MANAGEMENT; 2019; UPDATE; REPERFUSION; EFFICACY; SAFETY;
D O I
10.1161/SVIN.124.001563
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background Intra-arterial infusion of an adjunctive thrombolytic agent after macrovascular recanalization by endovascular thrombectomy was regarded as a promising strategy to promote outcomes of patients with stroke. Given the characteristics of urokinase as an affordable, available, and widely applied medication, especially in Eastern countries, this trial aims to assess the safety and efficacy of intra-arterial urokinase as adjunct to endovascular thrombectomy in improving outcomes among patients with anterior large-vessel occlusion stroke after excellent to complete reperfusion.Methods The POST-UK (Adjunctive Intra-Arterial Urokinase After Successful Endovascular Thrombectomy in Patients With Large Vessel Occlusion Stroke) trial is a multicenter, prospective, randomized, open-label, blinded-end point trial conducted in China. The planned sample size is 498. Those eligible patients with anterior circulation large-vessel occlusion stroke and achieving excellent to complete reperfusion by endovascular thrombectomy are planned to be consecutively randomized in a 1:1 ratio to the experimental group (a single dose of intra-arterial urokinase) or to standard of care.Results The primary outcome is a freedom from disability (modified Rankin Scale score of 0-1) at 90 +/- 7 days. The safety outcomes are mortality within 90 +/- 7 days and symptomatic intracranial hemorrhage within 48 hours.Conclusion The POST-UK trial will provide valuable insight of efficacy and safety of intra-arterial urokinase in patients with large-vessel occlusion stroke after achieving excellent to complete reperfusion by endovascular thrombectomy.
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页数:8
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