Ying Gao
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
Authors
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 | Jan 27, 2023 |
Journal | Stroke and Vascular Neurology |
Publisher | BMJ Publishing Group |
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 |
Files
INSPIRES protocol-supplementary tables-20221227
(267 Kb)
PDF
svn-2022-002084.full
(1.1 Mb)
PDF
Publisher Licence URL
https://creativecommons.org/licenses/by-nc/4.0/
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