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

NCT03062397 — Phase 2, Unknown, 110 participants, Jeil Pharmaceutical Co., Ltd.

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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

RegistryNCT03062397
StatusUnknown
PhasePhase 2
Study typeInterventional; randomized, sequential, masking: quadruple, treatment
Enrollment110 (Estimated)
SponsorJeil Pharmaceutical Co., Ltd. (Industry)
ConditionsAcute Ischemic Stroke
InterventionsJPI-289 Low-dose, JPI-289 High-dose, Placebo (Drug)
Datesstart 2016-12-09, primary completion 2020-12-01 (estimated), completion 2021-12-01 (estimated), first posted 2017-02-23, last updated 2019-11-18
Locations15 sites in South Korea

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-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Low-dose groupExperimentalDrug: JPI-289 Low-doseJPI-289 Low dose or placebo
High-dose groupExperimentalDrug: JPI-289 High-doseJPI-289 High dose or placebo
Placebo groupPlacebo comparatorDrug: PlaceboSame dosage of JPI-289 low and high dose
  • JPI-289 Low-dose (Drug): JPI-289 Low dose will be intravenously administered during 24 hours
  • JPI-289 High-dose (Drug): JPI-289 High dose will be intravenously administered during 24 hours
  • Placebo (Drug): Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours

+Outcome measures

Primary outcomes

  • Infact growth ratio from baseline [4 days from baseline]

+Eligibility

Sex: All, ages: 19 Years to any

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.

+Locations (15)

FacilityCityCountryStatus
Dong-A University HospitalBusanSouth KoreaRecruiting
Inje University Busan Paik HospitalBusanSouth KoreaRecruiting
Gyeongsang National University Changwon HospitalChangwonSouth KoreaRecruiting
Yeungnam University Medical CenterDaeguSouth KoreaRecruiting
Chonnam National University HospitalGwangjuSouth KoreaRecruiting
Inje University Ilsan Paik HospitalGyeonggi-doSouth KoreaRecruiting
Seoul National University Bundang HospitalGyeonggi-doSouth KoreaRecruiting
Catholic Kwandong University International St. Mary'S HospitalIncheonSouth KoreaRecruiting
Jeju National University HospitalJeju CitySouth KoreaRecruiting
Gyeongsang National University HospitalJinjuSouth KoreaRecruiting
Pusan National University HospitalPusanSouth KoreaRecruiting
Ewha Womans University Seoul HospitalSeoulSouth KoreaRecruiting
Hanyang University HospitalSeoulSouth KoreaRecruiting
Korea University Guro HospitalSeoulSouth KoreaRecruiting
Seoul National University HospitalSeoulSouth KoreaRecruiting

My Notes