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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02070471
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):

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)

Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction Drug: Placebo Drug: LC28-0126 Dose A Drug: LC28-0126 Dose B Drug: LC28-0126 Dose C Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2014
Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LC28-0126 Dose A
LC28-0126 Dose A
Drug: LC28-0126 Dose A
LC28-0126 Dose A
Experimental: LC28-0126 Dose B
LC28-0126 Dose B
Drug: LC28-0126 Dose B
LC28-0126 Dose B
Experimental: LC28-0126 Dose C
LC28-0126 Dose C
Drug: LC28-0126 Dose C
LC28-0126 Dose C
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. AUC of CK-MB for 72 hours post PCI [ Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h ]

Secondary Outcome Measures :
  1. AUC of Troponin I and CK for 72h post PCI [ Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h ]
  2. Infarct size and myocardial function assessed by CMR and Echocardiogram [ Time Frame: Day 4, 30 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070471


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
More Information

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02070471     History of Changes
Other Study ID Numbers: LG-CYCL002
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: September 2015

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases