Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases
Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial
First author：Yuesong Pan, Xia Meng
Corresponding author：Yongjun Wang
essential_information
- Person in charge：Yuesong Pan, Xia Meng
- Data Sources： OTHERS
- Number of papers：OTHERS20220089
- Published time：2022-04-07
2022-04-07
Published articles
Journal： Stroke and Vascular Neurology
Publication type: Protocol
IF(IF): 9.893
PMID: 35393360 Link To Pubmed Full text Download
Background And Purpose
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.
Method
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.
Conclusion
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.
Main results
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.