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

Abstract

BackgroundIndobufen 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.AimTo 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.DesignThe 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 outcomesThe 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.DiscussionThe 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 numberNCT03871517.

Chinese expert consensus on anti-thrombotic therapy for pan-vascular diseases (2023 edition)

“…Clopidogrel [44] , aspirin-dipyridamole combination [70–71] , and cilostazol [72–73] have been shown to be at least non-inferior to aspirin in the secondary prevention of ischemic stroke/TIA. In patients with acute moderate-to-severe ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score, 4–18), indobufen did not achieve noninferiority to aspirin, and the two groups were similar in terms of bleeding and overall adverse events [74] .…”

Indobufen versus aspirin in patients with acute ischaemic stroke in China (INSURE): a randomised, double-blind, double-dummy, active control, non-inferiority trial

“…All participants or their representatives provided written informed consent before enrolment. Details of the rationale and design of this study have been described previously 20 and the protocol was attached in the supplement. In brief, patients with acute moderate to severe ischaemic stroke, aged 18 to 80 years, with a National Institutes of Health Stroke Scale (NIHSS) score of 4-18, who could be randomised within 72 hours after symptoms onset (the time last seen normal) and sign informed consent were eligible for enrolment into the trial.…”

Dual Antiplatelet Therapy: A Concise Review for Clinicians

“…Indobufen, an antiplatelet agent used in Europe, has effectively reduced the risk of recurrent strokes [10]. Indobufen is a reversible inhibitor of COX and has similar effects to aspirin [11].…”