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Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial: rationale and design
  1. Hong-Qiu Gu1,
  2. Xue-Wei Xie1,
  3. Jing Jing1,
  4. Xia Meng1,
  5. Wei Lv1,
  6. Jian-Dong Yu1,
  7. Xiang-Ping Lv1,
  8. Hao Li1,
  9. Yi-Long Wang1,2,
  10. Yong-Jun Wang1,2,3,4
  1. 1 China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  2. 2 Vascular Neurology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
  3. 3 Beijing Key Laboratory of Translational Medicine for Cerebrovascular Disease, Beijing, China
  4. 4 Center for Stroke, Beijing Institute for Brain Disorders, Beijing, China
  1. Correspondence to Dr Yong-Jun Wang; yongjunwang{at}ncrcnd.org.cn

Abstract

Backgrounds Embolic stroke is one of the main mechanisms of ischaemic stroke. Even if treated with recommended antithrombotic agents, stroke recurrence remains high. The Shuxuetong injection, a purified extract of traditional Chinese medicine widely used for thrombus diseases in clinical practice in China, could be a promising agent to prevent stroke recurrence.

Aims To describe the design of the Shuxuetong injection for prevention of recurrence in acute ischaemic stroke with embolism mechanisms.

Design The Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial to evaluate the efficacy and safety of Shuxuetong injection in reducing recurrence or silent new ischaemic lesions on patients with acute embolic stroke within 10 days. An estimated 2416 patients with embolic stroke within 72 hours of symptom onset from 80 hospitals will be randomly assigned to one of two groups receiving Shuxuetong injection or placebo injection for 10 days. The primary endpoint is symptomatic or asymptomatic new cerebral infarction within 10 days after randomisation.

Conclusion The SPACE Trial will provide valuable evidence for the efficacy and safety of Shuxuetong injection for the prevention of stroke recurrence in patients with imaging-defined embolic stroke.

Clinical trial registration NCT03090113.

  • Stroke
  • Lesion
  • MRI
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/svn-2019-000293

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    Footnotes

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    • H-QG, X-WX, JJ and XM contributed equally.

    • Contributors H-QG, X-WX, JJ, HL, Y-LW and Y-JW conceived the study and oversaw all scientific aspects of its implementation. H-QG, X-WX and JJ drafted the manuscript. XM, WL, X-PL and J-DY recruited hospitals and operated the SPACE programme.

    • Funding This work was supported by grants from the Ministry of Science and Technology of the People’s Republic of China [2017YFC1310901, 2017YFC1307905,2018YFC1312903], grants from Beijing Municipal Administration of Hospitals’ Mission Plan [SML20150502], grants from National Natural Science Foundation of China [81600999], grants from Beijing Municipal Science & Technology Commission [D171100003017002, D151100002015003] and grants from National Science and Technology Major Project [2014ZX09201022-010,2017ZX09304018] and Mudanjiang Youbo Pharmaceutical Co., Ltd.

    • Competing interests The SPACE programme is an investigator-initiated study and mainly funded by the Ministry of Science and Technology of the People’s Republic of China. Mudanjiang Youbo Pharmaceutical Co., Ltd partly funded this programme; however, the company was not involved in the study design, data collection, data cleaning, data analysis, data interpretation and manuscript writing.

    • Patient consent for publication Not required.

    • Ethics approval The ethics committee of Beijing Tiantan Hospital，ID: KY2016-045-03.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request at yongjunwang@ncrcnd.org.cn