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: Placebo; Drug: LC28-0126 Dose A; Drug: LC28-0126 Dose B; Drug: 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

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-10
• Last Update Submitted: 2016-05-10
• Study First Posted: 2016-05-12
• Last Update Posted: 2016-05-12
• Primary Completion: 2018-08

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