Clinical trial NCT03062397: Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Infact growth ratio from baseline
timeFrame: 4 days from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Catholic Kwandong University International St. Mary'S Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: