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Rationale and Design of a randomized double-blind 2 × 2 factorial trial comparing the effect of a 3-month intensive statin and antiplatelet therapy for patients with acute mild ischemic stroke or high-risk TIA with intracranial or extracranial atherosclerosis (INSPIRES)

Gao, Ying; Pan, Yuesong; Han, Shangrong; Chen, Weiqi; Jing, Jing; Wang, Chunjuan; Yang, Yingying; Wang, Tingting; Meng, Xia; Zhao, Xingquan; Liu, Liping; Li, Hao; Johnston, S Claiborne; Amarenco, Pierre; Bath, Philip M; Wang, Yongjun; Wang, Yilong

Rationale and Design of a randomized double-blind 2 × 2 factorial trial comparing the effect of a 3-month intensive statin and antiplatelet therapy for patients with acute mild ischemic stroke or high-risk TIA with intracranial or extracranial atherosclerosis (INSPIRES) Thumbnail


Authors

Ying Gao

Yuesong Pan

Shangrong Han

Weiqi Chen

Jing Jing

Chunjuan Wang

Yingying Yang

Tingting Wang

Xia Meng

Xingquan Zhao

Liping Liu

Hao Li

S Claiborne Johnston

Pierre Amarenco

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

Yongjun Wang

Yilong Wang



Abstract

Background: It remains unclear if intensive antiplatelet and statin treatments begun within 24–72 hours of cerebral ischaemic events from intracranial or extracranial atherosclerosis is effective or safe.
Methods: The Intensive Statin and Antiplatelet Therapy for High-risk Intracranial or Extracranial Atherosclerosis (INSPIRES) trial is a randomised, double-blind, placebo-controlled, multicentre and 2×2 factorial trial. 6100 individuals between the ages of 35 and 80 who have experienced a mild ischaemic stroke or high-risk transient ischaemic attack (TIA) within the previous 72 hours that is attributed to ≥50% atherosclerotic stenosis of a major intracranial or extracranial artery or multiple infarctions of atherosclerotic origin will be enrolled in the trial. Eligible subjects will be randomised 1:1:1:1 to one of four groups: (1) intensive antiplatelet therapy (combined clopidogrel and aspirin for days 1–21, then aspirin placebo and clopidogrel for days 22–90) plus immediate intensive statin therapy(atorvastatin at a dose of 80 mg daily for the first 21 days, then 40 mg daily for days 22–90); (2) intensive antiplatelet therapy plus delayed intensive statin therapy (atorvastatin placebo for days 1–3, followed by 40 mg per day of atorvastatin for days 4–90); (3) standard antiplatelet therapy (combination of clopidogrel placebo with aspirin for 90 days) plus immediate intensive statin therapy and (4) standard antiplatelet therapy plus delayed intensive statin therapy. The primary efficacy endpoint is any new stroke (ischaemic or haemorrhagic) within 90 days after randomisation. The primary safety endpoint is moderate to severe bleeding at 90 days.
Conclusion: The INSPIRES trial will assess the efficacy and safety of intensive antiplatelet therapy and immediate intensive statin therapy begun within 72 hours of onset in decreasing the recurrent stroke at 90 days in patients with acute mild ischaemic stroke or high-risk TIA of intracranial or extracranial atherosclerosis origin.

Citation

Gao, Y., Pan, Y., Han, S., Chen, W., Jing, J., Wang, C., …Wang, Y. (2023). Rationale and Design of a randomized double-blind 2 × 2 factorial trial comparing the effect of a 3-month intensive statin and antiplatelet therapy for patients with acute mild ischemic stroke or high-risk TIA with intracranial or extracranial atherosclerosis (INSPIRES). Stroke and Vascular Neurology, 8(3), Article e002084. https://doi.org/10.1136/svn-2022-002084

Journal Article Type Article
Acceptance Date Jan 8, 2023
Online Publication Date Jan 27, 2023
Publication Date 2023-06
Deposit Date Jan 12, 2023
Publicly Available Date Mar 29, 2024
Journal Stroke and Vascular Neurology
Peer Reviewed Peer Reviewed
Volume 8
Issue 3
Article Number e002084
DOI https://doi.org/10.1136/svn-2022-002084
Public URL https://nottingham-repository.worktribe.com/output/15935803
Publisher URL https://svn.bmj.com/content/early/2023/01/26/svn-2022-002084

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