Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
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
1 other identifier
interventional
110
1 country
15
Brief Summary
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2016
Longer than P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2016
CompletedFirst Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 18, 2019
November 1, 2019
4 years
February 20, 2017
November 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Infact growth ratio from baseline
4 days from baseline
Study Arms (3)
Low-dose group
EXPERIMENTALJPI-289 Low dose or placebo
High-dose group
EXPERIMENTALJPI-289 High dose or placebo
Placebo group
PLACEBO COMPARATORSame dosage of JPI-289 low and high dose
Interventions
JPI-289 Low dose will be intravenously administered during 24 hours
JPI-289 High dose will be intravenously administered during 24 hours
Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
February 23, 2017
Study Start
December 9, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
November 18, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share