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
| Registry | NCT03062397 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, sequential, masking: quadruple, treatment |
| Enrollment | 110 (Estimated) |
| Sponsor | Jeil Pharmaceutical Co., Ltd. (Industry) |
| Conditions | Acute Ischemic Stroke |
| Interventions | JPI-289 Low-dose, JPI-289 High-dose, Placebo (Drug) |
| Dates | start 2016-12-09, primary completion 2020-12-01 (estimated), completion 2021-12-01 (estimated), first posted 2017-02-23, last updated 2019-11-18 |
| Locations | 15 sites in South Korea |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Acute Ischemic Stroke All trials of JPI-289 Low-dose All trials of JPI-289 High-dose
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Low-dose group | Experimental | Drug: JPI-289 Low-dose | JPI-289 Low dose or placebo |
| High-dose group | Experimental | Drug: JPI-289 High-dose | JPI-289 High dose or placebo |
| Placebo group | Placebo comparator | Drug: Placebo | Same dosage of JPI-289 low and high dose |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Dong-A University Hospital | Busan | South Korea | Recruiting |
| Inje University Busan Paik Hospital | Busan | South Korea | Recruiting |
| Gyeongsang National University Changwon Hospital | Changwon | South Korea | Recruiting |
| Yeungnam University Medical Center | Daegu | South Korea | Recruiting |
| Chonnam National University Hospital | Gwangju | South Korea | Recruiting |
| Inje University Ilsan Paik Hospital | Gyeonggi-do | South Korea | Recruiting |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea | Recruiting |
| Catholic Kwandong University International St. Mary'S Hospital | Incheon | South Korea | Recruiting |
| Jeju National University Hospital | Jeju City | South Korea | Recruiting |
| Gyeongsang National University Hospital | Jinju | South Korea | Recruiting |
| Pusan National University Hospital | Pusan | South Korea | Recruiting |
| Ewha Womans University Seoul Hospital | Seoul | South Korea | Recruiting |
| Hanyang University Hospital | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital | Seoul | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |