Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
NCT ID: NCT06548971
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1184 participants
INTERVENTIONAL
2024-11-07
2026-03-31
Brief Summary
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Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear.
The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Interventional group
Patients in the interventional group will receive early antiplatelet treatment with oral aspirin within 3 hours of initiating intravenous thrombolysis. In addition, the best medical management will be administered according to the guidelines.
Aspirin
Patients in the interventional group will chew 300mg of aspirin enteric-coated tablets as soon as possible after randomization. If swallowing difficulties arise, the tablets can be crushed and administered via a nasogastric tube.
Best medical management
Patients in both groups will receive the best medical management according to the guidelines.
Control group
Patients in the control group will receive placebos within 3 hours of initiating intravenous thrombolysis. In addition, the best medical management will be administered according to the guidelines.
Placebo
Patients in the control group will chew 300mg of placebos as soon as possible after randomization. If swallowing difficulties arise, the placebo can be crushed and administered via a nasogastric tube.
Best medical management
Patients in both groups will receive the best medical management according to the guidelines.
Interventions
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Aspirin
Patients in the interventional group will chew 300mg of aspirin enteric-coated tablets as soon as possible after randomization. If swallowing difficulties arise, the tablets can be crushed and administered via a nasogastric tube.
Placebo
Patients in the control group will chew 300mg of placebos as soon as possible after randomization. If swallowing difficulties arise, the placebo can be crushed and administered via a nasogastric tube.
Best medical management
Patients in both groups will receive the best medical management according to the guidelines.
Eligibility Criteria
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Inclusion Criteria
2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
3. Residual NIHSS score \> 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization.
4. Informed consent obtained from patients or an authorized representative.
Exclusion Criteria
2. Intracranial hemorrhage confirmed by imaging post-thrombolysis.
3. Definite or suspected cardioembolic stroke.
4. Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis), hypercoagulable states, or hematological disorders.
5. Use of antiplatelet therapy within one week prior to stroke onset, novel anticoagulant drugs within 48 hours prior to stroke onset, or treatment with warfarin with an international normalized ratio (INR)\>1.7.
6. Prior history of moderate or severe ischemic stroke events with residual neurological disability.
7. Pre-stroke mRS score \> 1.
8. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2 points.
9. Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsible artery supply area.
10. Known contraindications for antiplatelet therapy, such as coagulation disorders, or systemic bleeding
11. History of aspirin allergy.
12. Anticipated indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state)
13. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \< 30 mL/min or serum creatinine \> 220 μmol/L \[2.5 mg/dL\]), severe hepatic insufficiency (serum alanine aminotransferase \[ALT\] \>2 times the upper limit of normal, or serum aspartate aminotransferase \[AST\] \>2 times the upper limit of normal), severe heart failure (New York Heart Association \[NYHA\] Functional Classification Class III or IV)
14. Severe non-cardiovascular complications with an expected survival of less than 6 months.
15. Unavailability for follow-up.
16. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
17. Current participation in another therapeutic study with ongoing treatment and follow-up.
18. Other conditions that make the patient unsuitable for participation in the study as determined by the investigator.
18 Years
ALL
No
Sponsors
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Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Professor
Locations
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The Third The People's Hospital Of Bengbu
Bengbu, Anhui, China
Suzhou municipal hospital
Suzhou, Anhui, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Aerospace central hospital
Haidian, Beijing Municipality, China
Beijing Pinggu District Hospital
Pinggu, Beijing Municipality, China
Beijing Luhe Hospital affiliated to Capital Medical University
Tongzhou, Beijing Municipality, China
Fujian university affiliated provincial hospital
Fuzhou, Fujian, China
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
Xiamen Xinglin hospital
Xiamen, Fujian, China
Zhangzhou Hospital of Fujian Province
Zhangzhou, Fujian, China
Brain Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Guigang people's hospitalv
Guigang, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
The Second Affiliated Hospital of Guizhou Medical University
Kaili, Guizhou, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Cangzhou combination of Chinese traditional and western medicine hospital
Cangzhou, Hebei, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Hejian city People's Hospital
Cangzhou, Hebei, China
Handan Central Hospital
Handan, Hebei, China
Handan first hospital
Handan, Hebei, China
The First Hospital Of Qiqihar
Qiqihar, Heilongjiang, China
Hua county People's Hospital
Anyang, Henan, China
Jun county people's hospital
Hebi, Henan, China
Jiaozuo Second People's Hospital
Jiangzuo, Henan, China
First People's Hospital of Luoyang
Luoyang, Henan, China
Luoyang Yanshi People's Hospital
Luoyang, Henan, China
Nanyang nanshi hospital
Nanyang, Henan, China
Huanghe Sanmenxia hospital
Sanmenxia, Henan, China
Shangqiu Third People's Hospital
Shangqiu, Henan, China
Shangqiu First People's Hospital
Shangqiu, Henan, China
Ningling county people's hospital
Shangqucun, Henan, China
Xihua People's Hospital
Zhoukou, Henan, China
Luyi county people's hospital
Zhoukou, Henan, China
Zhumadian Central Hospital
Zhumadian, Henan, China
The Third People's Hospital of Hubei Province
Hainan, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
Changde Taoyuan County People's Hospital
Changde, Hunan, China
Chenzhou first people's hospital
Chenzhou, Hunan, China
Liuyang Jili Hospital
Guankou, Hunan, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Affiliated Hospital of Inner Mongolia University for the Nationalities
Tongliao, Inner Mongolia, China
Ulanqab Central Hospital
Ulanqab, Inner Mongolia, China
Zha Lan Tun Shi Zhong Meng Yi Yuan
Zhalantun, Inner Mongolia, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Jingdezhen NO.1 People's Hospital
Jingdezhen, Jiangxi, China
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Anshan Changda hospital
Anshan, Liaoning, China
Donggang city Central Hospital
Dandong, Liaoning, China
Fushun Mining Bureau General Hospital
Fushun, Liaoning, China
Togtoh county hospital
Neimeng, Neimeng, China
Dongying people's hospital
Dongying, Shandong, China
Shengli oilfield central hospital
Dongying, Shandong, China
Shandong province qianfoshan hospital
Jinan, Shandong, China
Jinan Third People's Hospital
Jinan, Shandong, China
Liaocheng people's hospital
Liaocheng, Shandong, China
The Third People Hospital In Liaocheng
Liaocheng, Shandong, China
Gaotang county people's hospital
Liaocheng, Shandong, China
Pingdu city traditional Chinese medicine hospital
Qingdao, Shandong, China
Juxian county people's hospital
Rizhao, Shandong, China
Rizhao traditional Chinese medicine hospital
Rizhao, Shandong, China
Shandong health group feicheng hospital
Taian, Shandong, China
Weihai Municipal Hospital
Weihai, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Weinan central hospital
Weinan, Shanxi, China
Shenzhen Second People's Hospital
Shenzhen, Shenzhen, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Ya 'an People's Hospital
Ya'an, Sichuan, China
Shihezi City People's Hospital
Shihezi, Xinjiang, China
Haiyan People's Hospital
Jiaxing, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Bin Ye, M.D.
Role: primary
Lei Zhang
Role: primary
Wenbo Zhao, M.D.
Role: primary
Peifu Wang
Role: primary
Yifei Cheng
Role: primary
Lipeng Cai
Role: primary
Yingchao He
Role: primary
Yihong Zhan, M.D.
Role: primary
Caitang Wu, M.D.
Role: primary
Tingyu Yi
Role: primary
Lixuan Zhan, M.D.
Role: primary
Xinming Li
Role: primary
Xuan Chen, M.D.
Role: primary
Changsong Wu, M.D.
Role: primary
Bin Liu
Role: primary
Yonglin Shan
Role: primary
Zhen Hong, M.D.
Role: primary
Lixin Wu
Role: primary
Shejun Feng
Role: primary
Liping Cheng
Role: primary
Chenghe Sun, M.D.
Role: primary
Hongling Guo
Role: primary
Beihai Jiang
Role: primary
Bo LI
Role: primary
Jinfeng Shi
Role: primary
Yang Zhou, M.D.
Role: primary
Junfeng Shi, M.D.
Role: primary
Meng Xue, M.D.
Role: primary
Yaping Jing
Role: primary
Hong Yang
Role: primary
Zhixiang Sui
Role: primary
Chaoqun Li, M.D.
Role: primary
Hao Liang
Role: primary
Ligong Gao
Role: primary
Fangyan Gong
Role: primary
Jun Wen
Role: primary
Hui Tan, M.D.
Role: primary
Ganghua Feng, M.D.
Role: primary
Yong He, M.D.
Role: primary
Yong Liang, M.D.
Role: primary
Zhen Zhao, M.D.
Role: primary
Yaoming Xu, M.D.
Role: primary
Shuzhen Gong, M.D.
Role: primary
Chengyan Yang, M.D.
Role: primary
Qi Fang
Role: primary
Qi Fang
Role: primary
Mingchao Wu, M.D.
Role: primary
Jianglong Tu, M.D.
Role: primary
Fan Zhang, M.D.
Role: primary
Jing Li
Role: primary
Hong 113012 Zhang, M.D.
Role: primary
Meixiu Hao
Role: primary
Wenjun Zhang
Role: primary
Ye Lang
Role: primary
Weili Li
Role: primary
Peng Guo, M.D.
Role: primary
Weidong Liu
Role: primary
Ke Diao, M.D.
Role: primary
Huqing Li, M.D.
Role: primary
Hong Sui
Role: primary
Jiawen Sun
Role: primary
Lei Mu
Role: primary
Youfeng Si
Role: primary
Weibin Zhong, M.D.
Role: primary
Chao Wang, M.D.
Role: primary
Yahong Guo, M.D.
Role: primary
Pengcheng Fu
Role: primary
Changchuan Wu
Role: primary
Jian Wang
Role: primary
Feng Chen, M.D.
Role: primary
Zhenhua Xi, M.D.
Role: primary
References
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Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
Demaerschalk BM, Kleindorfer DO, Adeoye OM, Demchuk AM, Fugate JE, Grotta JC, Khalessi AA, Levy EI, Palesch YY, Prabhakaran S, Saposnik G, Saver JL, Smith EE; American Heart Association Stroke Council and Council on Epidemiology and Prevention. Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Feb;47(2):581-641. doi: 10.1161/STR.0000000000000086. Epub 2015 Dec 22.
Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.
Zinkstok SM, Roos YB; ARTIS investigators. Early administration of aspirin in patients treated with alteplase for acute ischaemic stroke: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):731-7. doi: 10.1016/S0140-6736(12)60949-0. Epub 2012 Jun 28.
Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
Other Identifiers
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TREND-IVT
Identifier Type: -
Identifier Source: org_study_id