Journal Article Epublish
PubMed: 42894564 DOI: 10.1016/j.lanwpc.2026.101995
Tirofiban vs standard antiplatelet therapy in acute branch atheromatous disease-related stroke: a multicenter, randomized, open-label, blinded-endpoint, parallel-group, phase III clinical trial.
Lancet Reg Health West Pac 75:101995
Authors: Shengde Li, Haizhou Hu, Dingding Zhang, Bin Liu, Mengfei Zhong, Lihua Wang, Qingsong Yang, Ping Zhang, Weili Zhao, Fengli Zhao, Yufeng Tang, Xiaoli Wang, Heng Li, Liwei Chen, Guofang Chen, Rui Wang, Aiqin Dong, Zhidong Zheng, Xiaona Wang, Qin Liu, Jiangtao Zhang, Jiacai Wang, Li Wang, Xin Li, Hong Chen, Junfang Ma, Yuhua Zhao, Yuhui Sha, Thanh Nguyen, Duolao Wang, Lixin Zhou, Yicheng Zhu, Bin Peng, Jun Ni
Affiliations
- Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
- Center for Prevention and Early Intervention, National Infrastructures for Translational Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
- First Department of Neurology, The Affiliated Hospital of North China University of Science and Technology, Tangshan, China.
- Department of Neurology, Shengli Oilfield Central Hospital, Dongying, China.
- Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China.
- Department of Neurology, The First People's Hospital of Shangqiu, Shangqiu, China.
- Department of Neurology, The First Affiliated Hospital of Henan Medical University (The First Affiliated Hospital of Xinxiang Medical University), Xinxiang, China.
- Department of Neurology, Affiliated Hospital of Chifeng University, Chifeng, China.
- Department of Neurology, The Second Hospital of Baoding, Baoding, China.
- Department of Neurology, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Mianyang, China.
- Department of Neurology II, Hengshui People's Hospital, Hengshui, China.
- Department of Neurology, Jinan Central Hospital, Jinan, China.
- Department of Neurology, Yellow River Sanmenxia Hospital, Sanmengxia, China.
- Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.
- Department of Neurology, Meihekou Central Hospital, Meihekou, China.
- The Third Department of Cerebrovascular Disease, Cangzhou Central Hospital, Cangzhou, China.
- Department of Neurology & Research Office, Beijing Shunyi Hospital, Capital Medical University Shunyi Teaching Hospital, China.
- Department of Neurology II, Botou City Hospital, Cangzhou, China.
- Department of Neurology, The Second People's Hospital of Yibin, Yibin, China.
- Department of Neurology, Chengde Central Hospital, Chengde, China.
- Department of Neurology, First People's Hospital of Yibin City, Yibin, China.
- Department of Neurology, The First Hospital of Tsinghua University, School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, China.
- Department of Neurology, The Second Hospital of Tianjin Medical University, China.
- Department of Neurology, Deyang Peopole's Hospital, Deyang, China.
- Department of Neurology and Psychiatry, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
- Department of Neurology, People's Hospital of Xizang Autonomous Region, Lhasa, China.
- Department of Neurology, Radiology, Boston Medical Center, Boston, USA.
- Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Abstract
BACKGROUND
Tirofiban is sometimes used empirically for branch atheromatous disease (BAD)-related stroke, but its benefit in this population remains unclear. This study aimed to assess the efficacy and safety of intravenous tirofiban administered within 48 h of onset in patients with acute BAD-related stroke.
METHODS
This multicentre, randomized, open-label, blinded-endpoint clinical trial enrolled patients with BAD-related stroke within 48 h of onset from 25 hospitals in China between 9 November 2023 and 22 November 2025. Eligible patients were randomly assigned to the tirofiban group (intravenously, 0.4 μg/kg per minute for 30 min, followed by a 0.1 μg/kg per minute for 47.5 h) or standard antiplatelet therapy group (oral aspirin with or without clopidogrel) for 48 h. The primary endpoint was an excellent functional outcome, defined as a score of 0 or 1 on the modified Rankin Scale at 90 days. Safety outcomes included major bleeding within 90 days. This trial was registered on ClinicalTrials.gov (NCT06037889).
FINDINGS
Among 516 patients randomized, 513 were included in the primary analysis (258 with tirofiban and 255 with standard antiplatelet therapy). An excellent functional outcome was observed in 181 of 258 patients (70.2%) in the tirofiban group and 178 of 255 (69.8%) in the standard antiplatelet therapy group (risk ratio, 1.01 [95% CI, 0.90-1.13]; P = 0.93). Major bleeding occurred in 0 of 259 participants in the tirofiban-exposed safety population and 1 of 245 (0.4%) in the standard-antiplatelet-exposed safety population.
INTERPRETATION
Among patients with acute BAD-related stroke, intravenous tirofiban administered within 48 h of onset without concomitant oral antiplatelet therapy was not superior to standard antiplatelet therapy for achieving an excellent functional outcome at 90 days. These findings should not be extrapolated to substantially earlier treatment or to other tirofiban-based antiplatelet strategies.
FUNDING
National High Level Hospital Clinical Research Funding, Capital's Funds for Health Improvement and Research, CAMS Innovation Fund for Medical Sciences (CIFMS), Noncommunicable Chronic Diseases-National Science and Technology Major Project, and China Shijiazhuang Pharmaceutical Company (CSPC) NBP Pharmaceurical Co., Ltd.
MeSH
Safety, Hemorrhage, Stroke, Tirofiban, Therapeutics