机构：[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.神经科系统神经内科首都医科大学宣武医院[2]Department of Emergency, Xuanwu Hospital, Capital Medical University, Beijing, China.内科系统急诊科首都医科大学宣武医院[3]Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China.科技平台低氧适应转化医学北京市重点实验室首都医科大学宣武医院[4]Stroke Center, Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.神经科系统神经内科首都医科大学宣武医院[5]Department of Neurology, Ordos Central Hospital, Ordos, Inner Mongolia, China.[6]Department of Neurology, Sinopharm North Hospital, Baotou, Inner Mongolia, China.[7]Department of Neurology, The Third People's Hospital of Hubei Province, Wuhan, Hubei, China.[8]Department of Neurology, Nanyang Second People's Hospital, Nanyang, Henan, China.[9]Department of Neurology, Tongliao City Hospital, Tongliao, Inner Mongolia, China.[10]Department of Neurology, Affiliated Hospital of Inner Mongolia Minzu University, Inner Mongolia, China.[11]Department of Neurology, Traditional Chinese Medicine Hospital of Tianjin Beichen District, Tianjin, China.[12]Department of Neurology, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China.[13]Department of Neurology, Nanyang Central Hospital, Nanyang, Henan, China.[14]Department of Neurology, Qianfo Mountain Hospital of Shandong University, Jinan, China.[15]School of Statistics, University of Minnesota at Twin Cities, Minneapolis.[16]Department of Neurology, Duke University School of Medicine, Durham, North Carolina.[17]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.神经科系统神经外科首都医科大学宣武医院
Evidence supports using antiplatelet therapy in patients with acute ischemic stroke. However, neurological deterioration remains common under the currently recommended antiplatelet regimen, leading to poor clinical outcomes.To determine whether intravenous tirofiban administered within 24 hours of stroke onset prevents early neurological deterioration in patients with acute noncardioembolic stroke compared with oral aspirin.This investigator-initiated, multicenter, open-label, randomized clinical trial with blinded end-point assessment was conducted at 10 comprehensive stroke centers in China between September 2020 and March 2023. Eligible patients were aged 18 to 80 years with acute noncardioembolic stroke within 24 hours of onset and had a National Institutes of Health Stroke Scale (NIHSS) score of 4 to 20.Patients were assigned randomly (1:1) to receive intravenous tirofiban or oral aspirin for 72 hours using a central, web-based, computer-generated randomization schedule; all patients then received oral aspirin.The primary efficacy outcome was early neurological deterioration (increase in NIHSS score ≥4 points) within 72 hours after randomization. The primary safety outcome was symptomatic intracerebral hemorrhage within 72 hours after randomization.A total of 425 patients were included in the intravenous tirofiban (n = 213) or oral aspirin (n = 212) groups. Median (IQR) age was 64.0 years (56.0-71.0); 124 patients (29.2%) were female, and 301 (70.8%) were male. Early neurological deterioration occurred in 9 patients (4.2%) in the tirofiban group and 28 patients (13.2%) in the aspirin group (adjusted relative risk, 0.32; 95% CI, 0.16-0.65; P = .002). No patients in the tirofiban group experienced intracerebral hemorrhage. At 90-day follow-up, 3 patients (1.3%) in the tirofiban group and 3 (1.5%) in the aspirin group died (adjusted RR, 1.15; 95% CI, 0.27-8.54; P = .63), and the median (IQR) modified Rankin scale scores were 1.0 (0-1.25) and 1.0 (0-2), respectively (adjusted odds ratio, 1.28; 95% CI, 0.90-1.83; P = .17).In patients with noncardioembolic stroke who were seen within 24 hours of symptom onset, tirofiban decreased the risk of early neurological deterioration but did not increase the risk of symptomatic intracerebral hemorrhage or systematic bleeding.ClinicalTrials.gov Identifier: NCT04491695.
基金：
This trial was
investigator-initiated and managed and was funded
by grants from the Beijing Natural Science
Foundation (No. JQ22020), National Key R&D
Program of China (No. 2022YFC2408800 and
2016YFC1301502), Chinese National Ministry of Science and Technology, and Beijing Municipal
Science & Technology Commission
(Z201100006820143)
第一作者机构：[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
共同第一作者：
通讯作者：
通讯机构：[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.[17]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.[*1]Department of Neurosurgery,Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China[*2]Department of Neurology,Xuanwu Hospital, Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing 100053, China
推荐引用方式(GB/T 7714)：
Zhao Wenbo,Li Sijie,Li Chuanhui,et al.Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial[J].JAMA Neurology.2024,doi:10.1001/jamaneurol.2024.0868.
APA：
Zhao Wenbo,Li Sijie,Li Chuanhui,Wu Chuanjie,Wang Junmei...&Ji Xunming.(2024).Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial.JAMA Neurology,,
MLA：
Zhao Wenbo,et al."Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial".JAMA Neurology .(2024)
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