NCT07754825尚未招募2 期
A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of LT3001 in Participants With Acute Ischemic Stroke (AIS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of Participants by mRS（Modified Rankin Scale） score (0 - 1)
研究概览
简要总结
This phase II clinical study is designed to evaluate the efficacy and safety of LT3001 in the treatment of acute ischemic stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute ischemic stroke that causes evaluable neurological impairment;
- •6 points ≤ NIHSS score ≤ 25 points at randomization;
- •Participants who are able to receive the investigational drug within 24 hours after the onset of stroke;
- •Female Participants of childbearing potential or male Participants 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;
- •All participants sign the informed consent form by themselves or their guardians after receiving complete study information.
排除标准
- •Participants have received or plan to receive endovascular treatment and/or intravenous thrombolytic therapyduring this onset period;
- •Presence of disturbances of consciousness at screening and NIHSS 1a ≥ 2 points;
- •Neurological signs have improved rapidly and spontaneously at screening;
- •Participants who have used or are using protocol-prohibited medications after the onset;
- •Participants with pre-stroke disability;
- •Imaging evidence of intracranial hemorrhagic diseases, intraparenchymal brain tumor, arteriovenous malformation, aortic arch dissection, other central nervous system lesions that may increase the risk of hemorrhage, or arterial aneurysm requiring treatment;
- •Massive infarction on imaging;
- •Participants who are unable to cooperate due to epileptic seizure at the onset of stroke or other concomitant mental disorders or are unwilling to cooperate;
- •Participants previously diagnosed with concurrent malignant tumors who are currently undergoing anti-tumor treatment or have an expected survival of less than 3 months；
- •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 Participants, or women of childbearing potential with positive pregnancy test results;
- •International normalized ratio > 1.7 or prothrombin time > 15 s;
- •Participants with a history of serious hypersensitivity;
- •Participants who experienced AIS, ICH, acute myocardial infarction or serious head trauma before screening;
- •Participants who underwent any major surgery before screening;
- •Participants with a history of active digestive ulcer before screening;
- •Participants who experienced hemorrhagic disease before screening;
- •Participants who underwent arterial puncture at the site not easy for hemostasis by compression before screening;
- •Presence of active hepatitis, cirrhosis, or severe renal insufficiency;
- •Participants 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.
研究组 & 干预措施
LT3001 Drug:high dose
Experimental
干预措施: LT3001 Drug:high dose (Drug)
LT3001 Drug: low dose
Experimental
干预措施: LT3001 Drug: low dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants by mRS（Modified Rankin Scale） score (0 - 1)
时间窗: Day 90 after the first dose
次要结局
- Proportion of Participants with a BI score of ≥ 95 points and ≥ 75 points(Day 30 and Day 90 after the first dose)
- Incidence Adverse Events(Approximately 2 years)
- Proportion of Participants by mRS score (0 - 2)(Day 30 and Day 90 after the first dose)
- Proportion of Participants by mRS score (0 - 1)(Day 30 after the first dose)
- mRS displacement analysis(Day 30 and Day 90 after the first dose)
- Proportion of Participants with an NIHSS score of ≤ 1 point and/or with a decrease of ≥ 4 points from baseline in NIHSS score(Day 30 and Day 90 after the first dose)
- Absolute change from baseline in NIHSS score(Day 3、Day 7、Day 14 and Day 30 after the first dose)
研究者
研究点 (1)
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