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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062397
• Other study ID #: JPI-289-P2
• Status: Recruiting
• Phase: Phase 2
• Start date: December 9, 2016
• Est. completion date: December 2021

Study information

• Verified date: November 2019
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: Byung Woo Yoon, MD., PhD
• Email: bwyoon[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Drug:
• JPI-289 Low-dose
JPI-289 Low dose will be intravenously administered during 24 hours
• JPI-289 High-dose
JPI-289 High dose will be intravenously administered during 24 hours
• Placebo
Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Inje University Ilsan Paik Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Catholic Kwandong University International St. Mary'S Hospital	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infact growth ratio from baseline		4 days from baseline