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Intracoronary Darbepoetin-alpha to Reduce The Infarct Size and Post-Infarct Remodeling

NCT01538771 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-06-19

No results posted yet for this study

Summary

Prospective, randomized and open label trial

Hypothesis

* Infusion of intracoronary darbepoetin-alpha at the time of reperfusion may reduce infarct size and post-infarct pathologic left ventricular remodeling in patients with ST-segment elevation myocardial infarction.

Methods

* Randomization into control group or treatment group
* Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire balloon system simultaneously with first balloon inflation and conventional treatment
* Control group : conventional treatment

Endpoints

* peak CK-MB \& troponin levels : baseline,6h,12hr,18hr, 24hr, 36hr and 48hr
* MRI at baseline : infarct size, area at risk and salvaged myocardium
* MRI at 4 months : prevalence of pathologic left ventricle remodeling (definition: increase of end-diastolic volume index \> 20% compared to baseline)
* safety endpoint : cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptom, bleeding and urgent target lesion revascularization

Conditions

Interventions

DRUG

Darbepoetin alfa

Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment

DRUG

Control Saline

Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Dong-Ju Choi, MD, PhD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-09-30
Completion
2013-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01538771 on ClinicalTrials.gov