NCT02770664

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

May 8, 2016

Last Update Submit

May 10, 2016

Conditions

ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • AUC of Troponin I for 72 hours post PCI

    pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

Secondary Outcomes (5)

  • AUC of CK-MB for 72 hours post PCI

    pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

  • AUC of CK for 72 hours post PCI

    pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

  • Infarct size assessed by Cardiac MRI

    Day 4, 30

  • Myocardial function assessed by Cardiac MRI

    Day 4, 30

  • Myocardial function assessed by Echocardiogram

    Day 4, 30

Study Arms (4)

LC28-0126 Dose A

EXPERIMENTAL
Drug: LC28-0126 Dose A

LC28-0126 Dose B

EXPERIMENTAL
Drug: LC28-0126 Dose B

LC28-0126 Dose C

EXPERIMENTAL
Drug: LC28-0126 Dose C

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Placebo

Placebo
LC28-0126 Dose ADRUG

LC28-0126 Dose A

LC28-0126 Dose A
LC28-0126 Dose BDRUG

LC28-0126 Dose B

LC28-0126 Dose B
LC28-0126 Dose CDRUG

LC28-0126 Dose C

LC28-0126 Dose C

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Left Main disease
  • Multi-vessel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2016

First Posted

May 12, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2018

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

KR(1)