Tests LT3001 for acute ischemic stroke in adults
Tests the drug LT3001 against a placebo in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke
Key facts
- Where
- Baotou, Beijing, Changchun, Chaoyang, Daqing, Guangzhou, Hangzhou, Hengshui, Huai'an, Liaocheng, Linfen, Luoyang, Mianyang, Nanyang, Pingxiang, Shanghai, Suzhou, Taizhou, Wuhan, Xi’an, Xianyang, Xuzhou, and Zhanjiang, ChinaSee the 28 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05686642, who can take part
Where in China
- Inner Mongolia Baogang HospitalBaotou, ChinaTaking people
- The First Affiliated Hospital of Baotou Medical CollegeBaotou, ChinaTaking people
- Beijing Luhe Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaTaking people
- Beijing Tsinghua Changgung HospitalBeijing, ChinaTaking people
- The First Bethune Hospital of Jilin UniversityChangchun, ChinaTaking people
- Beipiao Central HospitalChaoyang, ChinaTaking people
- Daqing Oilfield General HospitalDaqing, ChinaTaking people
- The First Affiliated Hospital of Jinan UniversityGuangzhou, ChinaTaking people
- Zhejiang HospitalHangzhou, ChinaTaking people
- Harrison International Peace HospitalHengshui, ChinaTaking people
- Huai'an Second People's HospitalHuai'an, ChinaTaking people
- Liaocheng People's HospitalLiaocheng, ChinaTaking people
- Linfen Central HospitalLinfen, ChinaTaking people
- Linfen People's HospitalLinfen, ChinaTaking people
- Luoyang Third People's HospitalLuoyang, ChinaTaking people
- The Third Hospital of MianyangMianyang, ChinaTaking people
- Nanshi Hospital of NanyangNanyang, ChinaTaking people
- Pingxiang People's HospitalPingxiang, ChinaTaking people
- Shanghai Pudong HospitalShanghai, ChinaTaking people
- The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Taizhou First People's HospitalTaizhou, ChinaTaking people
- Taizhou Municipal HospitalTaizhou, ChinaTaking people
- Zhongnan Hospital of Wuhan UniversityWuhan, ChinaTaking people
- Xi'an Gaoxin HospitalXi’an, ChinaTaking people
- Yan'an University Xianyang HospitalXianyang, ChinaTaking people
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
- Central people' s hospital of zhanjiangZhanjiang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Pharmaceuticals Holding Co., Ltd
- Trial code
- NCT05686642
- Record updated
- 30 April 2026
- Original description
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic strokeRead full original descriptionShow less
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)
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
Inclusion: Subjects aged between 18 and 80 years at screening; 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: 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; Subjects who have used or are using protocol-prohibited medications after the onset; 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; Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg after active antihypertensive therapy; Subjects who underwent any major surgery before screening; Subjects who have participated in another investigational study and used investigational product before screening; Subjects with pre-stroke disability; 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; Acute hemorrhage tendency; Active visceral hemorrhage; Subjects with a history of serious hypersensitivity; Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening; Subjects with a history of active digestive ulcer before screening; Subjects who experienced hemorrhagic disease before screening; Serious hepatic impairment or serious renal insufficiency; Other conditions unsuitable for participation in this study determined by the Investigator; Blood glucose level < 50 mg/dL or > 400 mg/dL; Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points; Neurological signs have improved rapidly and spontaneously at screening; Massive infarction on imaging; Lactating or pregnant subjects, or women of childbearing potential with positive pregnancy test results; International normalized ratio > 1.7 or prothrombin time > 15 s; Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening.