Effect of intravenous urokinase vs best medicine treatment on functional outcome for patients with acute minor stroke (TRUST): a randomized controlled trial.
Yongli Tao, Yuan Gao, Lu Zhao, Yafang Xu, Chenyang Jiang, Kai Liu, Hui Fang, Lulu Pei, Xin Wang, Rui Zhang, Jun Wu, Jing Yang, Xinsheng Han, Hongling Guo, Baoguo Xue, Jinlou Li, Yuqian Liu, Hongqiu Gu, Kejin Du, Xin Cheng, Qiang Dong, Duolao Wang, Ferdinando S Buonanno, MingMing Ning, Yuming Xu, Bo Song
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引用次数: 0
Abstract
Background: The benefits of intravenous thrombolysis in patients with acute minor stroke remain controversial. For the aim of providing a better therapeutic strategy, high-quality trials are required to validate the efficacy of thrombolytic medicine other than intravenous recombinant tissue plasminogen and tenecteplase. In the trial, we evaluate the efficacy and safety of urokinase (UK) in acute minor stroke.
Methods: This multicenter, open-label, blinded-endpoint, randomized controlled clinical trial enrolled patients with minor stroke within 6 h of symptom onset, with a NIHSS score ≤ 5. The trial was conducted at 25 hospitals in China between October 2020 and February 2023. Eligible patients were randomized to the UK group (1,000,000 U) or the best medicine treatment group. The responsible investigator recommended and implemented the best medicine treatment based on guidelines. The primary endpoint was an excellent functional outcome, defined as a modified Rankin scale (mRS) score of 0-1 at 90 days. The primary safety outcome was symptomatic intracranial hemorrhage (sICH) within 36 h.
Results: A total of 999 patients were enrolled in the trial, the median age was 64 years, 371 (36.9%) were women; the median (IQR) NIHSS score was 3 (2-4). At 90 days, the primary endpoint was observed in 427 patients (84.9%) in the UK group and 425 patients (85.7%) in the control group (adjusted risk ratio [RR] 1.00, 95% CI 0.96-1.05, p = 0.87). A total of 3 patients in the UK-treated (0.6%) group experienced sICH compared to 1 patient (0.2%) in the control group (RR 1.83, 95% CI 0.16-20.27, p = 0.62).
Conclusions: For patients with acute minor stroke treated within 6 h of symptom onset, UK intravenous thrombolysis treatment was not found to be beneficial in terms of excellent functional outcome at 90 days, whereas it was safe.
背景：急性轻微脑卒中患者静脉溶栓的益处仍然存在争议。为了提供更好的治疗策略，需要高质量的试验来验证除静脉注射重组组织型纤溶酶原和替尼替普酶外的溶栓药物的疗效。在试验中，我们评估尿激酶（UK）治疗急性轻微卒中的有效性和安全性。方法：该多中心、开放标签、盲终点、随机对照临床试验纳入症状出现6小时内、NIHSS评分≤5分的轻度脑卒中患者。该试验于2020年10月至2023年2月在中国的25家医院进行。符合条件的患者随机分为UK组（1,000,000 U）或最佳药物治疗组。负责研究者根据指南推荐并实施最佳药物治疗。主要终点是良好的功能结局，定义为90天时修改的Rankin量表（mRS）评分0-1。主要安全性终点为36 h内症状性颅内出血（siich）。结果：共有999例患者入组，中位年龄为64岁，其中371例（36.9%）为女性；NIHSS评分中位数（IQR）为3（2-4）。在第90天，英国组427例（84.9%）患者和对照组425例（85.7%）患者观察到主要终点（校正风险比[RR] 1.00, 95% CI 0.96-1.05, p = 0.87）。英国治疗组共有3例（0.6%）患者发生sICH，对照组1例（0.2%）患者发生sICH （RR 1.83, 95% CI 0.16-20.27, p = 0.62）。结论：对于症状出现后6小时内接受治疗的急性轻度卒中患者，英国静脉溶栓治疗在90天的功能结果方面没有很好的益处，但它是安全的。试验注册：ClinicalTrials.gov标识符：NCT04420351。
期刊介绍：
BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.
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