Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 28 locations
1
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, China, 101199
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2
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510630
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3
Luoyang Third People's Hospital
Luoyang, He'nan, China, 471002
Actively Recruiting
4
Harrison International Peace Hospital
Hengshui, Hebei, China, 053099
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5
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, 163001
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6
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
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7
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China, 014017
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8
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China, 750306
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9
Huai'an Second People's Hospital
Huai'an, Jiangsu, China, 223022
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10
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
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11
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
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12
Pingxiang People's Hospital
Pingxiang, Jiangxi, China, 337000
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13
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130061
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14
Beipiao Central Hospital
Chaoyang, Liaoning, China, 122199
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15
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252004
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16
Yan'an University Xianyang Hospital
Xianyang, Shanxi, China, 716099
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17
Xi'an Gaoxin Hospital
Xi’an, Shanxi, China, 710077
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18
The Third Hospital of Mianyang
Mianyang, Sichuan, China
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19
Zhejiang Hospital
Hangzhou, Zhejiang, China, 310013
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20
Taizhou Municipal Hospital
Taizhou, Zhejiang, China, 318000
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21
Taizhou First People's Hospital
Taizhou, Zhejiang, China, 318020
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22
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
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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
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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