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

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

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

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.