NCT03062397Unknown2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Infact growth ratio from baseline
研究概览
简要总结
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with acute ischemic stroke, aging ≥ 19
- •Confirmed to have acute anterior circulation cerebral artery occlusion in intracranial internal carotid artery (IICA) or middle cerebral artery (MCA) M1 segment by CT or MR angiography.
- •National Institutes of Health Stroke Scale(NIHSS) is 6~30 before endovascular recanalization therapy (ERT)
- •Subject who is reperfused with 2b or 3 stages of thrombolysis in cerebral infarction (TICI) (However, if angiography is conducted for thrombectomy after IV tPA treatment and the effect of tPA results in TICI 2b-3 reperfusion, the subject can participate)
- •Subject who can administer IP within 6.5 hrs of symptom development
- •Subject who can administer IP within 30 min of vascular reperfusion
- •Subject who can evaluate MRI within 90 min of vascular reperfusion
排除标准
- •Subject who is contraindicated for endovascular recanalization
- •Subject who has hypersensitivity to contrast agent or component of investigational product
- •Prohibited or unable to perform MRI test
- •Medical history that is related to bleeding
- •History of hemorrhagic stroke within 6 months of study participation
- •Subjects with chronic liver disorder
- •Kidney disorder (Serum creatinine > 3 mg/dL)
- •Life expectancy is less than 3 months due to concomitant disease other than stroke
- •Pregnant or lactating women
- •Those who have taken tirofiban (anticoagulant agent) during endovascular recanalization therapy
- •Those who have taken other investigational drugs and/or medical instruments 12 weeks prior to screening
- •Subject is unable to be followed up
- •Subject is deemed unable to participate the study in the opinion of the investigator.
研究组 & 干预措施
Low-dose group
Experimental
JPI-289 Low dose or placebo
干预措施: JPI-289 Low-dose (Drug)
High-dose group
Experimental
JPI-289 High dose or placebo
干预措施: JPI-289 High-dose (Drug)
Placebo group
Placebo Comparator
Same dosage of JPI-289 low and high dose
干预措施: Placebo (Drug)
结局指标
主要结局
Infact growth ratio from baseline
时间窗: 4 days from baseline
次要结局
未报告次要终点
研究者
研究点 (15)
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