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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
Unknown status
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
LG Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

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

Outcomes

Primary Outcome Measures

AUC of Troponin I for 72 hours post PCI

Secondary Outcome Measures

AUC of CK-MB for 72 hours post PCI
AUC of CK for 72 hours post PCI
Infarct size assessed by Cardiac MRI
Myocardial function assessed by Cardiac MRI
Myocardial function assessed by Echocardiogram

Full Information

First Posted
May 8, 2016
Last Updated
May 10, 2016
Sponsor
LG Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02770664
Brief Title
Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

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
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LC28-0126 Dose A
Arm Type
Experimental
Arm Title
LC28-0126 Dose B
Arm Type
Experimental
Arm Title
LC28-0126 Dose C
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
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 Troponin I for 72 hours post PCI
Time Frame
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Secondary 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
Title
AUC of CK for 72 hours post PCI
Time Frame
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
Title
Infarct size assessed by Cardiac MRI
Time Frame
Day 4, 30
Title
Myocardial function assessed by Cardiac MRI
Time Frame
Day 4, 30
Title
Myocardial function assessed by 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 left bundle-branch block (LBBB) 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, M.D., Ph.D.
Phone
82-2-2072-2226
First Name & Middle Initial & Last Name & Degree
Hyo-Soo Kim, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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