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Completed

NCT Number: NCT02070471

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

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)

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Key information

Conditions

ST-segment Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo

LC28-0126 Dose A

Drug

LC28-0126 Dose A

LC28-0126 Dose B

Drug

LC28-0126 Dose B

LC28-0126 Dose C

Drug

LC28-0126 Dose C

Primary outcomes

  1. AUC of CK-MB for 72 hours post PCI

    Time frame: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
First posted
Feb 25, 2014
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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