- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02770664
Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
May 10, 2016 updated by: LG Life Sciences
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Contact:
- Hyo-Soo Kim, M.D., Ph.D.
- Phone Number: 82-2-2072-2226
-
Principal Investigator:
- Hyo-Soo Kim, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
|
Experimental: LC28-0126 Dose A
|
LC28-0126 Dose A
|
Experimental: LC28-0126 Dose B
|
LC28-0126 Dose B
|
Experimental: LC28-0126 Dose C
|
LC28-0126 Dose C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC of Troponin I for 72 hours post PCI
Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
|
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC of CK-MB for 72 hours post PCI
Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
|
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
|
pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
|
Infarct size assessed by Cardiac MRI
Time Frame: Day 4, 30
|
Day 4, 30
|
Myocardial function assessed by Cardiac MRI
Time Frame: Day 4, 30
|
Day 4, 30
|
Myocardial function assessed by Echocardiogram
Time Frame: Day 4, 30
|
Day 4, 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
May 8, 2016
First Submitted That Met QC Criteria
May 10, 2016
First Posted (Estimate)
May 12, 2016
Study Record Updates
Last Update Posted (Estimate)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LG-CYCL004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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