Back to resultsPhase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
Primary Purpose
ST-segment Elevation Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
LC28-0126 Dose A
LC28-0126 Dose B
LC28-0126 Dose C
Sponsored by
About this trial
This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
LC28-0126 Dose A
LC28-0126 Dose B
LC28-0126 Dose C
Placebo
Arm Description
LC28-0126 Dose A
LC28-0126 Dose B
LC28-0126 Dose C
Placebo
Outcomes
Primary Outcome Measures
AUC of CK-MB for 72 hours post PCI
Secondary Outcome Measures
AUC of Troponin I and CK for 72h post PCI
Infarct size and myocardial function assessed by CMR and Echocardiogram
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02070471
Brief Title
Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LC28-0126 Dose A
Arm Type
Experimental
Arm Description
LC28-0126 Dose A
Arm Title
LC28-0126 Dose B
Arm Type
Experimental
Arm Description
LC28-0126 Dose B
Arm Title
LC28-0126 Dose C
Arm Type
Experimental
Arm Description
LC28-0126 Dose C
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
LC28-0126 Dose A
Intervention Description
LC28-0126 Dose A
Intervention Type
Drug
Intervention Name(s)
LC28-0126 Dose B
Intervention Description
LC28-0126 Dose B
Intervention Type
Drug
Intervention Name(s)
LC28-0126 Dose C
Intervention Description
LC28-0126 Dose C
Primary Outcome Measure Information:
Title
AUC of CK-MB for 72 hours post PCI
Time Frame
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Secondary Outcome Measure Information:
Title
AUC of Troponin I and CK for 72h post PCI
Time Frame
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Title
Infarct size and myocardial function assessed by CMR and Echocardiogram
Time Frame
Day 4, 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
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