Key result
The INSURE trial is designed to 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.
Why the study?
Indobufen is effective in ischaemic heart and peripheral vascular diseases, but whether it is an alternative antiplatelet agent for ischaemic stroke remains unclear.
Does indobufen prevent new stroke in patients with moderate to severe ischaemic stroke compared to aspirin?
RCT
Double-blind, double-dummy
1:1
Yes
Does indobufen prevent new stroke in patients with moderate to severe ischaemic stroke compared to aspirin?
The INSURE trial is designed to evaluate whether indobufen is non-inferior to aspirin for preventing recurrent stroke in patients with acute moderate to severe ischemic stroke.
Whether indobufen is noninferior to aspirin for recurrent stroke remains unproven; INSURE will deliver the first RCT evidence in moderate-to-severe ischemic stroke.
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.
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Pan et al. (2022) conducted an RCT in Moderate to severe ischaemic stroke. Indobufen vs. Aspirin 100 mg once daily was evaluated on New stroke (ischaemic or haemorrhagic) within 3 months. The INSURE trial is designed to 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.
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