Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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

Key facts

Study ID

NCT05686642

Run by

Shanghai Pharmaceuticals Holding Co., Ltd

People needed

300

Starts

2023-04-06

Expected to finish

2026-12-12

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• 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.

You may not qualify if…

• 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;
• Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
• Neurological signs have improved rapidly and spontaneously at screening;
• Subjects who have used or are using protocol-prohibited medications after the onset;
• 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;
• Massive infarction on imaging;
• 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;
• Acute hemorrhage tendency;
• Blood glucose level < 50 mg/dL or > 400 mg/dL;
• Active visceral hemorrhage;
• 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 with a history of serious hypersensitivity;
• Subjects who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
• Subjects who underwent any major surgery before screening;
• Subjects with a history of active digestive ulcer before screening;
• Subjects who experienced hemorrhagic disease before screening;
• Subjects who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
• Serious hepatic impairment or serious renal insufficiency;
• Subjects who have participated in another investigational study and used investigational product before screening;
• Other conditions unsuitable for participation in this study determined by the Investigator.

Where it is running

• Beijing Luhe Hospital Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (enrolling)
• Luoyang Third People's Hospital — Luoyang, He'nan, China (enrolling)
• Harrison International Peace Hospital — Hengshui, Hebei, China (enrolling)
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China (enrolling)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China (enrolling)
• Inner Mongolia Baogang Hospital — Baotou, Inner Mongolia, China (enrolling)
• Huai'an Second People's Hospital — Huai'an, Jiangsu, China (enrolling)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)
• Pingxiang People's Hospital — Pingxiang, Jiangxi, China (enrolling)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Beipiao Central Hospital — Chaoyang, Liaoning, China (enrolling)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (enrolling)
• Yan'an University Xianyang Hospital — Xianyang, Shanxi, China (enrolling)
• Xi'an Gaoxin Hospital — Xi’an, Shanxi, China (enrolling)
• The Third Hospital of Mianyang — Mianyang, Sichuan, China (enrolling)
• Zhejiang Hospital — Hangzhou, Zhejiang, China (enrolling)
• Taizhou Municipal Hospital — Taizhou, Zhejiang, China (enrolling)
• Taizhou First People's Hospital — Taizhou, Zhejiang, China (enrolling)
• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (enrolling)
• Beijing Tsinghua Changgung Hospital — Beijing, China (enrolling)
• Linfen Central Hospital — Linfen, China (enrolling)
• Linfen People's Hospital — Linfen, China (enrolling)

Full record on ClinicalTrials.gov

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