Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
Phase 2
Completed
- Conditions
- ST-segment Elevation Myocardial Infarction
- Interventions
- Drug: LC28-0126 Dose ADrug: LC28-0126 Dose BDrug: PlaceboDrug: LC28-0126 Dose C
- Registration Number
- NCT02070471
- Lead Sponsor
- LG Life Sciences
- Brief Summary
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI (ST-segment Elevation Myocardial Infarction)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 LBBB(left bundle-branch block) 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 LC28-0126 Dose A LC28-0126 Dose A LC28-0126 Dose A LC28-0126 Dose B LC28-0126 Dose B LC28-0126 Dose B Placebo Placebo Placebo LC28-0126 Dose C LC28-0126 Dose C LC28-0126 Dose C
- Primary Outcome Measures
Name Time Method AUC of CK-MB for 72 hours post PCI pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
- Secondary Outcome Measures
Name Time Method Infarct size and myocardial function assessed by CMR and Echocardiogram Day 4, 30 AUC of Troponin I and CK for 72h post PCI pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of