Clinical trial NCT05686642: Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Adverse Events
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2)
timeFrame: Day 30 and Day 90 after the first dose
measure: 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
measure: Absolute change from baseline in NIHSS score
timeFrame: Day 3、Day 7、Day 14 and Day 30 after the first dose
measure: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Baotou
country: China
facility: Inner Mongolia Baogang Hospital
state: Inner Mongolia
city: Huai'an
country: China
facility: Huai'an Second People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Chaoyang
country: China
facility: Beipiao Central Hospital
state: Liaoning
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Xi'an
country: China
facility: Xi'an Gaoxin Hospital
state: Shanxi
city: Xianyang
country: China
facility: Yan'an University Xianyang Hospital
state: Shanxi
city: Mianyang
country: China
facility: The Third Hospital of Mianyang
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Municipal Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou First People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Linfen
country: China
facility: Linfen Central Hospital
city: Linfen
country: China
facility: Linfen People's Hospital
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
city: Zhanjiang
country: China
facility: Central People's Hospital of Zhanjiang
Study officials:
References: