Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Study Overview
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Brief Summary
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Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Official Title
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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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: JPI-289 Low-dose
* Drug: JPI-289 High-dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose group<br>JPI-289 Low dose or placebo | Drug: JPI-289 Low-dose<br>* JPI-289 Low dose will be intravenously administered during 24 hours<br>|
| Experimental: High-dose group<br>JPI-289 High dose or placebo | Drug: JPI-289 High-dose<br>* JPI-289 High dose will be intravenously administered during 24 hours<br>|
| Placebo Comparator: Placebo group<br>Same dosage of JPI-289 low and high dose | Drug: Placebo<br>* Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infact growth ratio from baseline |  | 4 days from baseline |