INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE

Summary

China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. The primary purpose of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.

Timeline

Start

2019-06-03

Primary completion

2022-03-01

Completion

2022-12-01

Publications

• Pan Y, Meng X, Yuan B, Johnston SC, Li H, Bath PM, Dong Q, Xu A, Jing J, Lin J, Jiang Y, Xie X, Jin A, Suo Y, Yang H, Feng Y, Zhou Y, Liu Q, Li X, Liu B, Zhu H, Zhao J, Huang X, Li H, Xiong Y, Li Z, Wang Y, Zhao X, Liu L, Wang Y; INSURE Investigators. Indobufen versus aspirin in patients with acute ischaemic stroke in China (INSURE): a randomised, double-blind, double-dummy, active control, non-inferiority trial. Lancet Neurol. 2023 Jun;22(6):485-493. doi: 10.1016/S1474-4422(23)00113-8. Epub 2023 Apr 27.
• Pan Y, Meng X, Chen W, Jing J, Lin J, Jiang Y, Johnston SC, Bath PM, Dong Q, Xu AD, Li H, Wang Y. Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial. Stroke Vasc Neurol. 2022 Oct;7(5):457-461. doi: 10.1136/svn-2021-001480. Epub 2022 Apr 7.

Drugs

Indications