Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial

Stroke and Vascular Neurology

article

Yuesong Pan¹  Xia Meng¹  Weiqi Chen¹  Jing Jing¹  Jinxi Lin¹  Yong Jiang¹  S Claiborne Johnston³  Philip M Bath⁴  Qiang Dong⁵  An-Ding Xu⁶  Hao Li¹  Yongjun Wang¹ 

[1] Department of Neurology , Beijing Tiantan Hospital, Capital Medical University;China National Clinical Research Center for Neurological Diseases;Dell Medical School , The University of Texas System;Stroke Trials Unit, Division of Clinical Neuroscience , University of Nottingham;Department of Neurology , Huashan Hospital, Fudan University;Department of Neurology , The First Affiliated Hospital of Jinan University;Advanced Innovation Center for Human Brain Protection , Beijing Tiantan Hospital, Capital Medical University;Research Unit of Artificial Intelligence in Cerebrovascular Disease , Chinese Academy of Medical Sciences

关键词: stroke;    clinical trial;    cerebral infarction;   

DOI  :  10.1136/svn-2021-001480

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background Indobufen can reversibly inhibit platelet aggregation and showed to be effective in the treatment of ischaemic heart and peripheral vascular diseases. However, it is unclear whether indobufen is an alternative antiplatelet agent for treatment of patients with ischaemic stroke.Aim To test whether indobufen is non-inferior to aspirin in reducing the risk of new stroke at 3 months in patients with moderate to severe ischaemic stroke.Design The Indobufen vs Aspirin in Acute Ischaemic Stroke (INSURE) is a randomised, double-blind, double-dummy, positive drug control, non-inferior multicentre clinical trial conducted in 200 hospitals in China. Participants will be randomised at a 1:1 ratio to receive either 100 mg indofufen two times daily or 100 mg aspirin once daily within 72 hours of the onset of symptoms from day 1 to 3 months.Study outcomes The primary efficacy outcome is a new stroke (ischaemic or haemorrhagic) within 3 months and the primary safety outcome is a severe or moderate bleeding event within 3 months.Discussion The INSURE trial will evaluate whether indobufen is non-inferior to aspirin in reducing the risk of new stroke at 3 months in patients with moderate to severe ischaemic stroke.Trial registration number NCT03871517.

【 授权许可】

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