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

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ClinicalTrials.gov Identifier: NCT03062397
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jeil Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: JPI-289 Low-dose Drug: JPI-289 High-dose Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 9, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low-dose group
JPI-289 Low dose or placebo
 Drug: JPI-289 Low-dose
JPI-289 Low dose will be intravenously administered during 24 hours
Experimental: High-dose group
JPI-289 High dose or placebo
 Drug: JPI-289 High-dose
JPI-289 High dose will be intravenously administered during 24 hours
Placebo Comparator: Placebo group
Same dosage of JPI-289 low and high dose
 Drug: Placebo
Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours


Outcome Measures
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Primary Outcome Measures :
  1. Infact growth ratio from baseline [ Time Frame: 4 days from baseline ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062397


Contacts
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Contact: Byung Woo Yoon, MD., PhD bwyoon@snu.ac.kr
Contact: Yong Woo Lee, MSC ywlee97@jeilpharm.co.kr

Locations
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Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of
Contact: Jae Kwan Cha, MD., PhD       nrcjk65@gmail.com   
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Eung-Gyu Kim, MD., PhD         
Gyeongsang National University Changwon Hospital Recruiting
Changwon, Korea, Republic of
Contact: Seunguk Jung, MD         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Jun Lee, MD., PhD       junlee@ynu.ac.kr   
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Man Seok Park, MD., PhD       mspark@chonnam.ac.kr   
Inje University Ilsan Paik Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Keun Sik Hong, MD., PhD       nrhks@paik.ac.kr   
Seoul National University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Moon Ku Han, MD., PhD       mkhan@snu.ac.kr   
Catholic Kwandong University International St. Mary'S Hospital Recruiting
Incheon, Korea, Republic of
Contact: Sang Joon An, MD         
Jeju National University Hospital Recruiting
Jeju, Korea, Republic of
Contact: Jay Chol Choi, M.D., PhD       jaychoi@jejunu.ac.kr   
Gyeongsang National University Hospital Recruiting
Jinju, Korea, Republic of
Contact: Chang Heon Kim, MD.,PhD       honey0407@naver.com   
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Contact: Sang Min Sung, MD. PhD       aminoff@hanmail.net   
Ewha Womans University Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: Tae Jin Song, MD., PhD         
Hanyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young Seo Kim, MD. PhD       aescula@daum.net   
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyung Mi Oh, MD., PhD       okyungmi@korea.ac.kr   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byung Woo Yoon, MD., PhD       bwyoon@snu.ac.kr   
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03062397    
Other Study ID Numbers: JPI-289-P2
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia