RT Journal Article
SR Electronic
T1 Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP e001480
DO 10.1136/svn-2021-001480
VO 7
IS 5
A1 Pan, Yuesong
A1 Meng, Xia
A1 Chen, Weiqi
A1 Jing, Jing
A1 Lin, Jinxi
A1 Jiang, Yong
A1 Johnston, S Claiborne
A1 Bath, Philip M
A1 Dong, Qiang
A1 Xu, An-Ding
A1 Li, Hao
A1 Wang, Yongjun
YR 2022
UL http://svn.bmj.com/content/7/5/e001480.abstract
AB 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.No data are available. Not applicable.