NCT04091945已完成2 期
A Phase IIa, Double-Blind, Single Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Potential Efficacy of LT3001 Drug Product in Subjects 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
- 已完成
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.
研究概览
简要总结
This is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase IIa clinical study, designed to evaluate LT3001 drug product versus placebo/control in subjects with AIS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 90 years
- •NIHSS of 4 to 30
- •Diagnosis of AIS within 24 hours after stroke symptoms onset
排除标准
- •Treatement with approved drug during the current AIS
- •Pre-stroke disability
- •Imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment
- •Suspected subarachnoid hemorrhage
- •Uncontrolled hypertension
- •INR >1.7 and/or abnormal aPTT or platelet count <100,000/mm3
- •Blood glucose concentration <50 mg/dL or >400 mg/dL
- •Lactating or pregnant subjects or those planning to become pregnant during the study
- •Received anticoagulants and/or antiplatelet therapy and glycoprotein IIb/IIIa inhibitors within 48 hours
- •AIS, myocardial infarction, serious head trauma or major surgery within 90 days
- •Bleeding event within 21 days
- •Puncture of noncompressible vessels within 7 days
- •Severe hepatic, renal, and/or infectious disease
研究组 & 干预措施
LT3001 Drug Product
Active Comparator
干预措施: LT3001 Drug Product (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Subject Have Symptomatic Intracranial Hemorrhage (sICH) of a Single Dose LT3001 Drug Product in Subjects With AIS.
时间窗: Within 36 hours
Compare the the percentage of subject having sICH between LT3001 drug product and Placebo.
次要结局
未报告次要终点
研究者
研究点 (10)
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