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

Phase 2

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: JPI-289 Low-dose; Drug: JPI-289 High-dose; Drug: Placebo

• Registration Number: NCT03062397
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-09
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low-dose group	JPI-289 Low-dose	JPI-289 Low dose or placebo
High-dose group	JPI-289 High-dose	JPI-289 High dose or placebo
Placebo group	Placebo	Same dosage of JPI-289 low and high dose

Primary Outcome Measures

Name	Time	Method
Infact growth ratio from baseline	4 days from baseline

Trial Locations

Locations (15)

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of

Ewha Womans University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Gyeongsang National University Changwon Hospital; 🇰🇷 Changwon, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Catholic Kwandong University International St. Mary'S Hospital; 🇰🇷 Incheon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Jinju, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of