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


Phase 2 Results N/A

Eligibility Criteria

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.