Current status of registrations in randomized controlled trials of endovascular therapy for ischemic stroke based on ClinicalTrials.gov
10.3760/cma.j.cn115354-20240816-00488
- VernacularTitle:基于ClinicalTrials.gov的缺血性脑卒中血管内治疗随机对照试验的注册现状分析
- Author:
Xiaole JIA
1
;
Wanwan ZHANG
1
;
Erlan YU
1
;
Xunming JI
1
;
Chuanjie WU
1
Author Information
1. 首都医科大学宣武医院神经内科，北京 100053
- Publication Type:Journal Article
- Keywords:
Ischemic stroke;
Endovascular treatment;
Randomized controlled trial
- From:
Chinese Journal of Neuromedicine
2025;24(1):37-43
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the current status of registrations in randomized controlled trials (RCTs) of endovascular therapy for ischemic stroke.Methods:The ClinicalTrials.gov database was searched for RCTs of endovascular therapy for ischemic stroke from January 1, 1994 to June 30, 2024. The registration time, sites, sample size, complete status and design types, contents, and outcome evaluation methods of the trails were analyzed.Results:(1) A total of 195 RCTs were included. Number of RCTs registrations during 1994-2004, 2005-2014 and 2015-2024 were 2, 21 and 172, respectively. RCTs registration sites mainly concentrated in China, the United States and France, with 90 (46.1%), 29 (14.9%) and 24 (12.3%) registrations, respectively. There were 43 RCTs with sample size≤100 (22.1%), 143 RCTs with sample size of 100-1000 (73.3%), and 9 RCTs with sample size ≥1000 (4.6%). Fifty-seven RCTs were completed (29.2%, the average time from registration to trial completion was 1044 days); 91 RCTs (46.7%) were in the recruitment or pre-recruitment states; 23 RCTs (11.8%) were suspended or terminated. (2) RCTs design types included parallel design ( n=189, 96.9%), factorial design ( n=2, 1.0%), group-sequential design ( n=2, 1.0%), cross-over design ( n=1, 0.5%), and single-arm design ( n=1, 0.5%). Forty-four open trials (22.6%) and 151 blinded trials (77.4%) were recorded; among the blind trials, 108 RCTs (71.5%) were single-blind design, 19 (12.6%) were double-blind design, and 24 RCTs (15.9%) were triple-blind design. (3) A total of 69 RCTs (35.4%) focused on drug use, including 23 trails related to arterial thrombolysis drugs (mainly alteplase and tenecteplase); 67 RCTs (34.4%) were about endovascular therapy and perioperative management, among which 27 trials compared the efficacy of endovascular therapy, intravenous thrombolysis or placebo; 49 RCTs (25.1%) were about equipment use during treatment. (4) Outcome evaluation method: modified Rankin scale was most frequently used (153 RCTs), followed by National Institutes of Health Stroke Scale (100 RCTs). Conclusions:In the past decade, the number of RCTs about endovascular treatment for ischemic stroke has increased rapidly, and most of them were multi-center and blinded RCTs investigating the selection of arterial thrombolytic drugs, optimization of thrombectomy devices, and perioperative management. China is particularly prominent in this area of research.
