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

ST-segment Elevation Myocardial Infarction Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02070471
• Other study ID #: LG-CYCL002
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 21, 2014
• Last updated: September 17, 2015
• Start date: January 2014

Study information

• Verified date: September 2015
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

Drug:
• Placebo
Placebo
• LC28-0126 Dose A
LC28-0126 Dose A
• LC28-0126 Dose B
LC28-0126 Dose B
• LC28-0126 Dose C
LC28-0126 Dose C

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of CK-MB for 72 hours post PCI		pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h	No
Secondary	AUC of Troponin I and CK for 72h post PCI		pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h	No
Secondary	Infarct size and myocardial function assessed by CMR and Echocardiogram		Day 4, 30	No