Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT05686642

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-04-30

300

Participants Needed

28

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke

CONDITIONS

Official Title

Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years at screening
  • Clinical diagnosis of acute ischemic stroke causing neurological impairment
  • NIHSS score between 4 and 25 points at randomization
  • Able to receive the investigational drug within 24 hours after stroke onset
  • Female participants of childbearing potential or male participants with partners of childbearing potential must use effective contraception during the study and for 3 months after the last dose
  • Signed informed consent form by participant or guardian after receiving full study information
Not Eligible

You will not qualify if you...

  • Received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy during this stroke event
  • Presence of consciousness disturbances at screening with NIHSS 1a score 2 points or higher
  • Rapid and spontaneous improvement of neurological signs at screening
  • Use of prohibited medications after stroke onset
  • Pre-stroke disability
  • Intracranial hemorrhagic diseases, brain tumors, arteriovenous malformation, aortic arch dissection, or central nervous system lesions increasing hemorrhage risk
  • Imaging evidence of arterial aneurysm requiring treatment
  • Massive infarction on imaging
  • Inability or unwillingness to cooperate due to seizures or mental disorders
  • Systolic blood pressure over 180 mmHg or diastolic over 100 mmHg after treatment
  • Acute bleeding tendency
  • Blood glucose below 50 mg/dL or above 400 mg/dL
  • Active internal bleeding
  • Pregnant or lactating, or positive pregnancy test in women of childbearing potential
  • INR over 1.7 or prothrombin time over 15 seconds
  • History of serious allergic reactions
  • Previous acute ischemic stroke, intracerebral hemorrhage, heart attack, or serious head trauma
  • Major surgery before screening
  • Active digestive ulcer history
  • Previous hemorrhagic disease
  • Recent arterial puncture at a site difficult to compress
  • Severe liver or kidney impairment
  • Participation in another investigational study and use of investigational products before screening
  • Any other condition deemed unsuitable by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

Beijing Luhe Hospital Capital Medical University

Beijing, Beijing Municipality, China, 101199

Actively Recruiting

2

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China, 510630

Actively Recruiting

3

Luoyang Third People's Hospital

Luoyang, He'nan, China, 471002

Actively Recruiting

4

Harrison International Peace Hospital

Hengshui, Hebei, China, 053099

Actively Recruiting

5

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China, 163001

Actively Recruiting

6

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071

Actively Recruiting

7

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China, 014017

Actively Recruiting

8

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China, 750306

Actively Recruiting

9

Huai'an Second People's Hospital

Huai'an, Jiangsu, China, 223022

Actively Recruiting

10

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215004

Actively Recruiting

11

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

12

Pingxiang People's Hospital

Pingxiang, Jiangxi, China, 337000

Actively Recruiting

13

The First Bethune Hospital of Jilin University

Changchun, Jilin, China, 130061

Actively Recruiting

14

Beipiao Central Hospital

Chaoyang, Liaoning, China, 122199

Actively Recruiting

15

Liaocheng People's Hospital

Liaocheng, Shandong, China, 252004

Actively Recruiting

16

Yan'an University Xianyang Hospital

Xianyang, Shanxi, China, 716099

Actively Recruiting

17

Xi'an Gaoxin Hospital

Xi’an, Shanxi, China, 710077

Actively Recruiting

18

The Third Hospital of Mianyang

Mianyang, Sichuan, China

Actively Recruiting

19

Zhejiang Hospital

Hangzhou, Zhejiang, China, 310013

Actively Recruiting

20

Taizhou Municipal Hospital

Taizhou, Zhejiang, China, 318000

Actively Recruiting

21

Taizhou First People's Hospital

Taizhou, Zhejiang, China, 318020

Actively Recruiting

22

Beijing Tiantan Hospital, Capital Medical University

Beijing, China, 100070

Actively Recruiting

23

Beijing Tsinghua Changgung Hospital

Beijing, China, 102218

Actively Recruiting

24

Linfen Central Hospital

Linfen, China

Actively Recruiting

25

Linfen People's Hospital

Linfen, China

Actively Recruiting

26

Nanshi Hospital of Nanyang

Nanyang, China

Actively Recruiting

27

Shanghai Pudong Hospital

Shanghai, China, 201399

Actively Recruiting

28

Central People's Hospital of Zhanjiang

Zhanjiang, China

Actively Recruiting

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Research Team

Y

Yongjun Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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