Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID06548971

Safety and Efficacy of Early Antiplatelet Treatment With Aspirin After Intravenous Thrombolysis for Acute Ischemic Stroke: A Multicenter, Randomized, Placebo-Controlled Clinical Trial

Led by Capital Medical University · Updated on 2025-12-19

1184

Participants Needed

71

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

CONDITIONS

Brief Title

Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute ischemic stroke treated with intravenous thrombolysis (alteplase or tenecteplase) within 4.5 hours of symptom onset or last known well
  • Able to receive study drug within 3 hours of starting intravenous thrombolysis
  • Residual NIH Stroke Scale score greater than 5 points one hour after thrombolysis and before randomization
  • Informed consent obtained from patient or authorized representative
Not Eligible

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 caused by 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 certain anticoagulants within 48 hours before stroke onset
  • Prior moderate or severe ischemic stroke with residual disability
  • Pre-stroke modified Rankin scale score greater than 1
  • Severe consciousness disturbance (NIHSS item 1a score 2 or higher)
  • Post-thrombolysis infarct larger than half the artery supply area
  • Known contraindications to antiplatelet therapy, including 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 kidney or liver insufficiency, or severe heart failure
  • Severe non-cardiovascular complications with expected survival under 6 months
  • Unavailability for follow-up
  • Presence of dementia, psychiatric, or neurological conditions complicating follow-up
  • Current participation in another therapeutic study with ongoing treatment and follow-up
  • Other conditions making participation unsuitable as determined by the investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 days after stroke

Participants receive early antiplatelet treatment with oral aspirin or placebo within 3 hours of starting intravenous thrombolysis, alongside best medical management according to guidelines.

Multiple visits within 7 days for neurological assessments

Follow-up

Duration - Up to 90 days after stroke

Participants are followed up to assess recovery and neurological outcomes after treatment.

Visits at 30 days and 90 days

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

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Research Team

X

XunMing Ji, MD, PD

W

Wenbo Zhao, MD, PD

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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Published Research Related To This Trial

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.

William J Powers, Alejandro A Rabinstein, Teri Ackerson...

https://pubmed.ncbi.nlm.nih.gov/31662037

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.

Bart M Demaerschalk, Dawn O Kleindorfer, Opeolu M Adeoye...

https://pubmed.ncbi.nlm.nih.gov/26696642

Early administration of aspirin in patients treated with alteplase for acute ischaemic stroke: a randomised controlled trial.

Sanne M Zinkstok, Yvo B Roos, ARTIS investigators

https://pubmed.ncbi.nlm.nih.gov/22748820

Safety and Efficacy of Early Aspirin Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT): Rationale and Design of a Multicenter, Randomized, Placebo-Controlled Clinical Trial.

Jing Wang, Sijie Li, Lan Liu...

https://pubmed.ncbi.nlm.nih.gov/41717940