Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

Phase 2

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Placebo

• Registration Number: NCT05686642
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-17
• Study Start: 2023-04-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-12-10
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Subjects aged between 18 and 80 years at screening;
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

1. Subjects have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapy recommended by Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018 during this onset period;
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence Adverse Events	Approximately 2 years	Adverse event type, incidence, duration, correlation with study drug

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2)	Day 30 and Day 90 after the first dose	Proportion of subjects by mRS score (0 - 2)
Proportion of subjects with an NIHSS（National Institute of Health stroke scale ） score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score	Day 14 after the first dose	Proportion of subjects with an NIHSS score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score
Absolute change from baseline in NIHSS score	Day 3、Day 7、Day 14 and Day 30 after the first dose	Absolute change from baseline in NIHSS score
Proportion of subjects with a BI（Barthel index） score of ≥ 95 points and ≥ 75 points	Day 30 and Day 90 after the first dose	Proportion of subjects with a BI score of ≥ 95 points and ≥ 75 points

Trial Locations

Locations (28)

Beijing Luhe Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China

Harrison International Peace Hospital; 🇨🇳 Hengshui, Hebei, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China

Luoyang Third People's Hospital; 🇨🇳 Luoyang, Henan, 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 Third Hospital of Mianyang; 🇨🇳 Mianyang, Sichuan, China

Nanshi Hospital of Nanyang; 🇨🇳 Nanyang, China

Shanghai Pudong Hospital; 🇨🇳 Shanghai, China

Central People's Hospital of Zhanjiang; 🇨🇳 Zhanjiang, China

The First Bethune Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Xi'an Gaoxin Hospital; 🇨🇳 Xi'an, Shanxi, China

Zhejiang Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beipiao Central Hospital; 🇨🇳 Chaoyang, Liaoning, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, China

Linfen People's Hospital; 🇨🇳 Linfen, China

Liaocheng People's Hospital; 🇨🇳 Liaocheng, Shandong, China

Yan'an University Xianyang Hospital; 🇨🇳 Xianyang, Shanxi, China

Taizhou First People's Hospital; 🇨🇳 Taizhou, Zhejiang, China

Taizhou Municipal Hospital; 🇨🇳 Taizhou, Zhejiang, China

Linfen Central Hospital; 🇨🇳 Linfen, China