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

Jeil Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: JPI-289 High-dose; Drug: JPI-289 Low-dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03062397

JPI-289-P2

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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110 participants in 3 patient groups, including a placebo group

Low-dose group

Experimental group

Description:

JPI-289 Low dose or placebo

Treatment:

Drug: JPI-289 Low-dose

High-dose group

Experimental group

Description:

JPI-289 High dose or placebo

Treatment:

Drug: JPI-289 High-dose

Placebo group

Placebo Comparator group

Description:

Same dosage of JPI-289 low and high dose

Treatment:

Drug: Placebo