Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

LG Life Sciences100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

ST-segment Elevation Myocardial Infarction

Interventions

PlaceboDRUG

Placebo

LC28-0126 Dose ADRUG

LC28-0126 Dose A

LC28-0126 Dose BDRUG

LC28-0126 Dose B

LC28-0126 Dose C

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

AUC of Troponin I for 72 hours post PCI

Time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

Secondary Outcomes

AUC of CK-MB for 72 hours post PCI

Time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

AUC of CK for 72 hours post PCI

Time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

Infarct size assessed by Cardiac MRI

Time frame: Day 4, 30

Myocardial function assessed by Cardiac MRI

Time frame: Day 4, 30

Myocardial function assessed by Echocardiogram

Time frame: Day 4, 30

Data from ClinicalTrials.gov

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