Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
Phase 2
- Conditions
- ST-segment Elevation Myocardial Infarction
- Interventions
- Drug: PlaceboDrug: LC28-0126 Dose ADrug: LC28-0126 Dose BDrug: LC28-0126 Dose C
- Registration Number
- NCT02770664
- Lead Sponsor
- LG Life Sciences
- Brief Summary
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment Elevation Myocardial Infarction (STEMI).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Age between 20 and 75
- Within 12 hours after the onset of chest pain
- ST-segment elevation of more than 0.1 mV in two contiguous leads or new left bundle-branch block (LBBB) patients
- Signed for written informed consent
Exclusion Criteria
- Left Main disease
- Multi-vessel disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - LC28-0126 Dose A LC28-0126 Dose A - LC28-0126 Dose B LC28-0126 Dose B - LC28-0126 Dose C LC28-0126 Dose C -
- Primary Outcome Measures
Name Time Method AUC of Troponin I for 72 hours post PCI pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
- Secondary Outcome Measures
Name Time Method Myocardial function assessed by Cardiac MRI Day 4, 30 Myocardial function assessed by Echocardiogram Day 4, 30 Infarct size assessed by Cardiac MRI Day 4, 30 AUC of CK for 72 hours post PCI pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h AUC of CK-MB for 72 hours post PCI pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of