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)
1 other identifier
interventional
60
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 21, 2014
CompletedFirst Posted
Study publicly available on registry
February 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedMay 10, 2016
September 1, 2015
1.4 years
February 21, 2014
May 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
AUC of CK-MB for 72 hours post PCI
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Secondary Outcomes (2)
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
Study Arms (4)
LC28-0126 Dose A
EXPERIMENTALLC28-0126 Dose A
LC28-0126 Dose B
EXPERIMENTALLC28-0126 Dose B
LC28-0126 Dose C
EXPERIMENTALLC28-0126 Dose C
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Left Main disease
- Multi-vessel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LG Life Scienceslead
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2014
First Posted
February 25, 2014
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Last Updated
May 10, 2016
Record last verified: 2015-09