Actively Recruiting
Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
Led by Capital Medical University · Updated on 2025-12-19
1184
Participants Needed
71
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of symptom onset or last known well time
- Able to receive study drug within 3 hours of starting intravenous thrombolysis
- National Institutes of Health Stroke Scale (NIHSS) score greater than 5 one hour after starting intravenous thrombolysis and before randomization
- Informed consent obtained from patient or authorized representative
You will not qualify if you...
- Stroke caused by definite large vessel occlusion confirmed by vessel imaging or scheduled for endovascular treatment
- Intracranial hemorrhage confirmed by imaging after thrombolysis
- Definite or suspected cardioembolic stroke
- Stroke due to other determined causes such as moyamoya disease, artery dissection, arteritis, hypercoagulable states, or hematological disorders
- Use of antiplatelet therapy within one week before stroke onset or novel anticoagulants within 48 hours before stroke onset, or warfarin with INR greater than 1.7
- Prior moderate or severe ischemic stroke with residual disability
- Pre-stroke modified Rankin scale score greater than 1
- Severe consciousness disturbance (NIHSS consciousness item 1a score of 2 or higher)
- Post-thrombolysis imaging showing infarct area larger than half of the responsible artery supply area
- Known contraindications to antiplatelet therapy such as coagulation disorders or systemic bleeding
- History of aspirin allergy
- Anticipated need for anticoagulant therapy during the study period
- Presence of malignant tumors, chronic hemodialysis, severe renal or hepatic insufficiency, or severe heart failure (NYHA Class III or IV)
- Severe non-cardiovascular complications with expected survival less than 6 months
- Unable to participate in follow-up
- Dementia, psychiatric disorders, or neurological conditions complicating follow-up
- Current participation in another therapeutic study with ongoing treatment and follow-up
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 71 locations
1
The Third The People's Hospital Of Bengbu
Bengbu, Anhui, China, 233000
Actively Recruiting
2
Suzhou municipal hospital
Suzhou, Anhui, China, 234000
Actively Recruiting
3
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
4
Aerospace central hospital
Haidian, Beijing Municipality, China, 100049
Actively Recruiting
5
Beijing Pinggu District Hospital
Pinggu, Beijing Municipality, China, 101200
Actively Recruiting
6
Beijing Luhe Hospital affiliated to Capital Medical University
Tongzhou, Beijing Municipality, China, 101149
Actively Recruiting
7
Fujian university affiliated provincial hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
8
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
9
Xiamen Xinglin hospital
Xiamen, Fujian, China, 361020
Not Yet Recruiting
10
Zhangzhou Hospital of Fujian Province
Zhangzhou, Fujian, China, 363000
Actively Recruiting
11
Brain Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China, 510180
Not Yet Recruiting
12
Guigang people's hospitalv
Guigang, Guangxi, China, 537100
Actively Recruiting
13
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543002
Actively Recruiting
14
The Second Affiliated Hospital of Guizhou Medical University
Kaili, Guizhou, China, 556099
Actively Recruiting
15
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570145
Actively Recruiting
16
Cangzhou combination of Chinese traditional and western medicine hospital
Cangzhou, Hebei, China, 061001
Actively Recruiting
17
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061012
Actively Recruiting
18
Hejian city People's Hospital
Cangzhou, Hebei, China, 062450
Actively Recruiting
19
Handan Central Hospital
Handan, Hebei, China, 056001
Actively Recruiting
20
Handan first hospital
Handan, Hebei, China, 056002
Actively Recruiting
21
The First Hospital Of Qiqihar
Qiqihar, Heilongjiang, China, 161005
Actively Recruiting
22
Hua county People's Hospital
Anyang, Henan, China, 456400
Actively Recruiting
23
Jun county people's hospital
Hebi, Henan, China, 458030
Actively Recruiting
24
Jiaozuo Second People's Hospital
Jiangzuo, Henan, China, 454001
Actively Recruiting
25
First People's Hospital of Luoyang
Luoyang, Henan, China, 471000
Actively Recruiting
26
Luoyang Yanshi People's Hospital
Luoyang, Henan, China, 471900
Actively Recruiting
27
Nanyang nanshi hospital
Nanyang, Henan, China, 473010
Not Yet Recruiting
28
Huanghe Sanmenxia hospital
Sanmenxia, Henan, China, 472000
Not Yet Recruiting
29
Shangqiu Third People's Hospital
Shangqiu, Henan, China, 476000
Actively Recruiting
30
Shangqiu First People's Hospital
Shangqiu, Henan, China, 476100
Actively Recruiting
31
Ningling county people's hospital
Shangqucun, Henan, China, 476700
Actively Recruiting
32
Xihua People's Hospital
Zhoukou, Henan, China, 466000
Actively Recruiting
33
Luyi county people's hospital
Zhoukou, Henan, China, 477200
Actively Recruiting
34
Zhumadian Central Hospital
Zhumadian, Henan, China, 463000
Actively Recruiting
35
The Third People's Hospital of Hubei Province
Hainan, Hubei, China, 430033
Actively Recruiting
36
The First People's Hospital of Changde City
Changde, Hunan, China, 415000
Actively Recruiting
37
Changde Taoyuan County People's Hospital
Changde, Hunan, China, 415099
Not Yet Recruiting
38
Chenzhou first people's hospital
Chenzhou, Hunan, China, 424499
Not Yet Recruiting
39
Liuyang Jili Hospital
Guankou, Hunan, China, 410300
Actively Recruiting
40
Xiangtan Central Hospital
Xiangtan, Hunan, China, 411100
Actively Recruiting
41
Zhuzhou Central Hospital
Zhuzhou, Hunan, China, 412007
Actively Recruiting
42
Affiliated Hospital of Inner Mongolia University for the Nationalities
Tongliao, Inner Mongolia, China, 028007
Actively Recruiting
43
Ulanqab Central Hospital
Ulanqab, Inner Mongolia, China, 012000
Actively Recruiting
44
Zha Lan Tun Shi Zhong Meng Yi Yuan
Zhalantun, Inner Mongolia, China, 162650
Actively Recruiting
45
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Actively Recruiting
46
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215021
Actively Recruiting
47
Jingdezhen NO.1 People's Hospital
Jingdezhen, Jiangxi, China, 333000
Actively Recruiting
48
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China, 330008
Actively Recruiting
49
Anshan Changda hospital
Anshan, Liaoning, China, 114000
Not Yet Recruiting
50
Donggang city Central Hospital
Dandong, Liaoning, China, 118300
Actively Recruiting
51
Fushun Mining Bureau General Hospital
Fushun, Liaoning, China
Not Yet Recruiting
52
Togtoh county hospital
Neimeng, Neimeng, China, 010200
Actively Recruiting
53
Dongying people's hospital
Dongying, Shandong, China, 257029
Actively Recruiting
54
Shengli oilfield central hospital
Dongying, Shandong, China, 257034
Actively Recruiting
55
Shandong province qianfoshan hospital
Jinan, Shandong, China, 250014
Actively Recruiting
56
Jinan Third People's Hospital
Jinan, Shandong, China, 250101
Actively Recruiting
57
Liaocheng people's hospital
Liaocheng, Shandong, China, 252000
Actively Recruiting
58
The Third People Hospital In Liaocheng
Liaocheng, Shandong, China, 252000
Actively Recruiting
59
Gaotang county people's hospital
Liaocheng, Shandong, China, 252800
Actively Recruiting
60
Pingdu city traditional Chinese medicine hospital
Qingdao, Shandong, China, 266700
Actively Recruiting
61
Juxian county people's hospital
Rizhao, Shandong, China, 276500
Actively Recruiting
62
Rizhao traditional Chinese medicine hospital
Rizhao, Shandong, China, 276800
Actively Recruiting
63
Shandong health group feicheng hospital
Taian, Shandong, China, 271614
Actively Recruiting
64
Weihai Municipal Hospital
Weihai, Shandong, China, 264200
Actively Recruiting
65
Zibo Central Hospital
Zibo, Shandong, China, 255020
Not Yet Recruiting
66
Weinan central hospital
Weinan, Shanxi, China, 714000
Not Yet Recruiting
67
Shenzhen Second People's Hospital
Shenzhen, Shenzhen, China, 518035
Actively Recruiting
68
Chengdu Second People's Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
69
Ya 'an People's Hospital
Ya'an, Sichuan, China, 625000
Actively Recruiting
70
Shihezi City People's Hospital
Shihezi, Xinjiang, China, 832000
Actively Recruiting
71
Haiyan People's Hospital
Jiaxing, Zhejiang, China, 314311
Actively Recruiting
Research Team
X
XunMing Ji, MD, PD
CONTACT
W
Wenbo Zhao, MD, PD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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