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Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
Sponsor: Capital Medical University
Summary
Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis. 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.
Official title: Safety and Efficacy of Treatment With Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT): A Multicenter, Randomized, Placebo-controlled, Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1184
Start Date
2024-11-07
Completion Date
2026-03
Last Updated
2025-12-19
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (71)
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