Efficacy and Safety of LT3001 on Treating the Acute Ischemic Stroke
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)
1 other identifier
interventional
300
1 country
28
Brief Summary
This phase II clinical study is designed to evaluate the safety and efficacy of LT3001 in the treatment of acute ischemic stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2023
Typical duration for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedStudy Start
First participant enrolled
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 12, 2026
April 30, 2026
April 1, 2026
3.7 years
January 9, 2023
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence Adverse Events
Adverse event type, incidence, duration, correlation with study drug
Approximately 2 years
Secondary Outcomes (4)
Proportion of subjects by mRS（Modified Rankin Scale） score (0 - 2)
Day 30 and Day 90 after the first dose
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
Absolute change from baseline in NIHSS score
Day 3、Day 7、Day 14 and Day 30 after the first dose
Proportion of subjects with a BI（Barthel index） score of ≥ 95 points and ≥ 75 points
Day 30 and Day 90 after the first dose
Study Arms (3)
LT3001 Drug:high dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORLT3001 Drug:low dose
EXPERIMENTALInterventions
Eligibility Criteria
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;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Beijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, 101199, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630, China
Luoyang Third People's Hospital
Luoyang, He'nan, 471002, China
Harrison International Peace Hospital
Hengshui, Hebei, 053099, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014017, China
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, 750306, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223022, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130061, China
Beipiao Central Hospital
Chaoyang, Liaoning, 122199, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252004, China
Yan'an University Xianyang Hospital
Xianyang, Shanxi, 716099, China
Xi'an Gaoxin Hospital
Xi’an, Shanxi, 710077, China
The Third Hospital of Mianyang
Mianyang, Sichuan, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310013, China
Taizhou Municipal Hospital
Taizhou, Zhejiang, 318000, China
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070, China
Beijing Tsinghua Changgung Hospital
Beijing, 102218, China
Linfen Central Hospital
Linfen, China
Linfen People's Hospital
Linfen, China
Nanshi Hospital of Nanyang
Nanyang, China
Shanghai Pudong Hospital
Shanghai, 201399, China
Central People's Hospital of Zhanjiang
Zhanjiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2023
First Posted
January 17, 2023
Study Start
April 6, 2023
Primary Completion (Estimated)
December 10, 2026
Study Completion (Estimated)
December 12, 2026
Last Updated
April 30, 2026
Record last verified: 2026-04