Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
NCT ID: NCT03062397
Last Updated: 2019-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
110 participants
INTERVENTIONAL
2016-12-09
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Low-dose group
JPI-289 Low dose or placebo
JPI-289 Low-dose
JPI-289 Low dose will be intravenously administered during 24 hours
High-dose group
JPI-289 High dose or placebo
JPI-289 High-dose
JPI-289 High dose will be intravenously administered during 24 hours
Placebo group
Same dosage of JPI-289 low and high dose
Placebo
Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
ALL
No
Sponsors
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Jeil Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Dong-A University Hospital
Busan, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Gyeongsang National University Changwon Hospital
Changwon, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Inje University Ilsan Paik Hospital
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Catholic Kwandong University International St. Mary'S Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Eung-Gyu Kim, MD., PhD
Role: primary
Seunguk Jung, MD
Role: primary
Sang Joon An, MD
Role: primary
Tae Jin Song, MD., PhD
Role: primary
Other Identifiers
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JPI-289-P2
Identifier Type: -
Identifier Source: org_study_id
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