Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
Overview
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 2020
Interventions
- Drug: JPI-289 Low-dose
- JPI-289 Low dose will be intravenously administered during 24 hours
- Drug: JPI-289 High-dose
- JPI-289 High dose will be intravenously administered during 24 hours
- Drug: Placebo
- Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours
Arms, Groups and Cohorts
- Experimental: Low-dose group
- JPI-289 Low dose or placebo
- Experimental: High-dose group
- JPI-289 High dose or placebo
- Placebo Comparator: Placebo group
- Same dosage of JPI-289 low and high dose
Clinical Trial Outcome Measures
Primary Measures
- Infact growth ratio from baseline
- Time Frame: 4 days from baseline
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Contact(s)
- Byung Woo Yoon, MD., PhD, bwyoon@snu.ac.kr
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