Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT02070471
First received: February 21, 2014
Last updated: September 17, 2015
Last verified: September 2015
  Purpose
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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • AUC of CK-MB for 72 hours post PCI [ Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC of Troponin I and CK for 72h post PCI [ Time Frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h ] [ Designated as safety issue: No ]
  • Infarct size and myocardial function assessed by CMR and Echocardiogram [ Time Frame: Day 4, 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2014
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 21, 2014
Last Updated: September 17, 2015
Health Authority: South Korea: Ministry of Food and Drug Safety

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

ClinicalTrials.gov processed this record on April 27, 2016