Overview

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

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
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.