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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Primary Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2016-05-08
• Last Update Posted: 2016-05-10

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
AUC of Troponin I and CK for 72h post PCI	pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Infarct size and myocardial function assessed by CMR and Echocardiogram	Day 4, 30

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of