> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-lt3001-on-treating-the-acute-ischemic-bc9da70f-70bb-41e3-8e9e-3f0e0c1964dd > Record changed: 2026-10-13 # Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke NCT05686642 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) Lead sponsor Shanghai Pharmaceuticals Holding Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) Start date 2023-04-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) Number of sites 28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Title and summary **Summary** This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Short title** Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Official title** A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Safety and Efficacy of LT3001 in Subjects With Acute Ischemic Stroke (AIS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Dates **Completion date** 2026-12-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **First posted** 2023-01-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Registry last updated** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Primary completion date** 2026-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Start date** 2023-04-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Number of sites** 28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Lead sponsor** Shanghai Pharmaceuticals Holding Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Identifiers **Registry ID** NCT05686642 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **ClinicalTrials.gov ID** NCT05686642 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Outcomes ### Primary outcomes 1. Incidence Adverse Events Timeframe: Approximately 2 years Adverse event type, incidence, duration, correlation with study drug ### Secondary outcomes 1. Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2) Timeframe: Day 30 and Day 90 after the first dose Proportion of subjects by mRS score (0 - 2) 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 Timeframe: 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 3. Absolute change from baseline in NIHSS score Timeframe: Day 3、Day 7、Day 14 and Day 30 after the first dose Absolute change from baseline in NIHSS score 4. Proportion of subjects with a BI（Barthel index） score of ≥ 95 points and ≥ 75 points Timeframe: Day 30 and Day 90 after the first dose Proportion of subjects with a BI score of ≥ 95 points and ≥ 75 points Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Sites - Beijing Luhe Hospital Capital Medical UniversityBeijing, ChinaRecruiting - The First Affiliated Hospital of Jinan UniversityGuangzhou, ChinaRecruiting - Luoyang Third People's HospitalLuoyang, ChinaRecruiting - Harrison International Peace HospitalHengshui, ChinaRecruiting - Daqing Oilfield General HospitalDaqing, ChinaRecruiting - Zhongnan Hospital of Wuhan UniversityWuhan, ChinaRecruiting - The First Affiliated Hospital of Baotou Medical CollegeBaotou, ChinaRecruiting - Inner Mongolia Baogang HospitalBaotou, ChinaRecruiting - Huai'an Second People's HospitalHuai'an, ChinaRecruiting - The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaRecruiting - The Affiliated Hospital of Xuzhou Medical UniversityXuzhou, ChinaRecruiting - Pingxiang People's HospitalPingxiang, ChinaRecruiting - The First Bethune Hospital of Jilin UniversityChangchun, ChinaRecruiting - Beipiao Central HospitalChaoyang, ChinaRecruiting - Liaocheng People's HospitalLiaocheng, ChinaRecruiting - Yan'an University Xianyang HospitalXianyang, ChinaRecruiting - Xi'an Gaoxin HospitalXi’an, ChinaRecruiting - The Third Hospital of MianyangMianyang, ChinaRecruiting - Zhejiang HospitalHangzhou, ChinaRecruiting - Taizhou Municipal HospitalTaizhou, ChinaRecruiting - Taizhou First People's HospitalTaizhou, ChinaRecruiting - Beijing Tiantan Hospital, Capital Medical UniversityBeijing, ChinaRecruiting - Beijing Tsinghua Changgung HospitalBeijing, ChinaRecruiting - Linfen Central HospitalLinfen, ChinaRecruiting - Linfen People's HospitalLinfen, ChinaRecruiting And 3 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05686642) ## Related records ### Drugs (2) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) ### Lead sponsors (1) - [Shanghai Pharmaceuticals Holding Co., Ltd](https://trialight.com/data/company/shanghai-pharmaceuticals-holding-co-ltd-264bedd6-993f-45e5-97be-0a714dcd3f5d.md) ### Conditions (2) - [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md) - [Transient ischemic attack](https://trialight.com/data/condition/transient-ischemic-attack-4355dfad-752a-55bb-8d3e-cd43c9c8144b.md) Primary condition ### Targets (3) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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