Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke
NCT ID: NCT05686642
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2023-04-06
2025-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LT3001 Drug:high dose
LT3001 Drug:high dose
Administered by intravenous infusion.
Placebo
Placebo
Administered by intravenous infusion.
LT3001 Drug:low dose
LT3001 Drug:low dose
Administered by intravenous infusion.
Interventions
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LT3001 Drug:high dose
Administered by intravenous infusion.
Placebo
Administered by intravenous infusion.
LT3001 Drug:low dose
Administered by intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment; 3.4 points ≤ NIHSS score ≤ 25 points at randomization;
4.Subjects who are able to receive the investigational drug within 24 hours after the onset of stroke; 5.Female subjects of childbearing potential or male subjects whose sexual partner are women of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the study period and for 3 months after the last dose; 6.All subjects sign the informed consent form by themselves or their guardians after receiving complete study information.
Exclusion Criteria
2. Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
3. Neurological signs have improved rapidly and spontaneously at screening;
4. Subjects who have used or are using protocol-prohibited medications after the onset;
5. Subjects with pre-stroke disability;
6. Subjects with intracranial hemorrhagic diseases, tumor in brain parenchyma, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or imaging evidence for arterial aneurysm requiring treatment;
7. Massive infarction on imaging;
8. Patients who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
9. Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg after active antihypertensive therapy;
10. Acute hemorrhage tendency;
11. Blood glucose level \< 50 mg/dL or \> 400 mg/dL;
12. Active visceral hemorrhage;
13. Lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results;
14. International normalized ratio \> 1.7 or prothrombin time \> 15 s;
15. Subjects with a history of serious hypersensitivity;
16. Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
17. Subjects who underwent any major surgery before screening;
18. Subjects with a history of active digestive ulcer before screening;
19. Subjects who experienced hemorrhagic disease before screening;
20. Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
21. Serious hepatic impairment or serious renal insufficiency;
22. Subjects who have participated in another investigational study and used investigational product before screening;
23. Other conditions unsuitable for participation in this study determined by the Investigator.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Luoyang Third People's Hospital
Luoyang, He'nan, China
Harrison International Peace Hospital
Hengshui, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Beipiao Central Hospital
Chaoyang, Liaoning, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Yan'an University Xianyang Hospital
Xianyang, Shanxi, China
Xi'an Gaoxin Hospital
Xi’an, Shanxi, China
The Third Hospital of Mianyang
Mianyang, Sichuan, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Taizhou Municipal Hospital
Taizhou, Zhejiang, China
Taizhou First People's Hospital
Taizhou, Zhejiang, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
Linfen Central Hospital
Linfen, , China
Linfen People's Hospital
Linfen, , China
Nanshi Hospital of Nanyang
Nanyang, , China
Shanghai Pudong Hospital
Shanghai, , China
Central People's Hospital of Zhanjiang
Zhanjiang, , China
Countries
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Central Contacts
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Facility Contacts
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Bo Liu
Role: primary
Dong Wang
Role: primary
Hongzhe Bei
Role: backup
Diwen Zhang
Role: primary
Hongguo Dai
Role: primary
Junfang Hao
Role: primary
Bin Liu
Role: primary
Hui Mai
Role: primary
Other Identifiers
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SPH-LT3001-202
Identifier Type: -
Identifier Source: org_study_id
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