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

Last updated: November 14, 2019
Sponsor: Jeil Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Occlusions

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT03062397
JPI-289-P2
  • Ages > 19
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with acute ischemic stroke, aging ≥ 19

  • Confirmed to have acute anterior circulation cerebral artery occlusion in intracranialinternal carotid artery (IICA) or middle cerebral artery (MCA) M1 segment by CT or MRangiography.

  • National Institutes of Health Stroke Scale(NIHSS) is 6~30 before endovascularrecanalization 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 treatmentand 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

Exclusion Criteria:

  • Subject who is contraindicated for endovascular recanalization

  • Subject who has hypersensitivity to contrast agent or component of investigationalproduct

  • 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 endovascularrecanalization therapy

  • Those who have taken other investigational drugs and/or medical instruments 12 weeksprior to screening

  • Subject is unable to be followed up

  • Subject is deemed unable to participate the study in the opinion of the investigator.

Study Design

Total Participants: 110
Study Start date:
December 09, 2016
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Dong-A University Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Inje University Ilsan Paik Hospital

    Gyeonggi-do,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Gyeonggi-do,
    Korea, Republic of

    Active - Recruiting

  • Catholic Kwandong University International St. Mary'S Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Jeju National University Hospital

    Jeju,
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospital

    Jinju,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.