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

作     者：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 M Bath Yongjun Wang Yilong Wang 

作者机构：Department of NeurologyBeijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological DiseasesBeijing Tiantan HospitalCapital Medical UniversityBeijingChina Dean's OfficeDell Medical SchoolUniversity of Texas at AustinAustinTexasUSA Department of Neurology and Stroke CenterAssistance Publique-Hôpitaux de Paris(APHP)Bichat HospitalINSERM LVTS-U1148University of ParisParisFrance Population Health Research InstituteMcMaster UniversityHamiltonOntarioCanada Stroke Trials UnitMental Health&Clinical NeuroscienceUniversity of NottinghamNottinghamUK Advanced Innovation Center for Human Brain ProtectionCapital Medical UniversityBeijingChina National Center for Neurological DiseasesBeijingChina Research Unit of Artificial Intelligence in Cerebrovascular DiseaseChinese Academy of Medical SciencesBeijingChina Chinese Institute for Brain ResearchBeijingChina 

出 版 物：《Stroke & Vascular Neurology》 (卒中与血管神经病学（英文）)

年 卷 期：2023年第8卷第3期

页      面：249-258,I0096-I0110页

核心收录：

学科分类：1002[医学-临床医学] 100204[医学-神经病学] 10[医学] 

基　　金：The study was supported by grants from the National Key R&D Program of China(No.2017YFC1307900,2017YFC1307905) The National Natural Science Foundation of China(No.81825007) Beijing Outstanding Young Scientist Program(No.BJJWZYJH01201910025030) Youth Beijing Scholar Program(No.010) Beijing Talent Project-Class A:Innovation and Development(No.2018A12) 'National Ten-Thousand Talent Plan'-Leadership of Scientific and Technological Innovation,Sanofi,and Beijing Jialin Pharmaceutical Co.LTD 

主　　题：intracranial atherosclerosis random 

摘      要：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 *** 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 *** 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 *** primary efficacy endpoint is any new stroke(ischaemic or haemorrhagic)within 90 days after *** primary safety endpoint is moderate to severe bleeding at 90 *** 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.