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Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo-Controlled Phase 2 Study to 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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02070471
Enrollment
60
Registered
2014-02-25
Start date
2014-01-31
Completion date
Unknown
Last updated
2016-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-segment Elevation Myocardial Infarction

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)

Interventions

DRUGPlacebo

Placebo

DRUGLC28-0126 Dose A

LC28-0126 Dose A

DRUGLC28-0126 Dose B

LC28-0126 Dose B

DRUGLC28-0126 Dose C

LC28-0126 Dose C

Sponsors

LG Life Sciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
AUC of CK-MB for 72 hours post PCIpre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

Secondary

MeasureTime frame
AUC of Troponin I and CK for 72h post PCIpre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Infarct size and myocardial function assessed by CMR and EchocardiogramDay 4, 30

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026