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

NCT ID: NCT01538771

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-02-28

Brief 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

Detailed Description

[Eligibility Criteria]

1. Patients, regardless of gender, at the age from 18 to 80 years were eligible if they had within 12 hours of onset of ST-segment myocardial infarction that was decided to treat with primary percutaneous coronary intervention.

[Exclusion criteria]

1. Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)

2. History of malignancy

3. Serious hematological disease

4. Current infectious disease requiring antibiotic therapy

5. Baseline creatinine level > 2.0 mg/dL or dependence on dialysis

6. Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast medium and darbepoetin-α

[Primary endpoint] Myocardial infarct size, estimated by measurement of peak levels of cardiac biomarker (CK-MB and troponin-I of the patients was followed for 48 hours at every 6 hours)

[Secondary end points]

1. The infarct size, measured as the area of delayed enhancement seen with cardiac magnetic resonance (CMR) imaging on average four days after ST-segment elevation myocardial infarction (baseline)

2. The proportion of area at risk (AAR) and salvaged myocardium, calculated by formula; [AAR - Infarct size] / AAR X 100 (%)

3. The change of left ventricular ejection fraction (LVEF), LV end-diastolic volume (LVEDV), and LV end-systolic volume (LVESV) assessed by CMR between four days and four months

4. LV remodeling index [(LVEDV at four months - baseline LVEDV) / baseline LVEDV X 100%] and the incidence of pathologic LV remodeling (LV remodeling index > 20%);

[Safety endpoints] The incidence of composites of the cardiovascular endpoints (cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemic stroke, hospital readmission with heart failure or ischemic symptoms, bleeding and urgent target lesion revascularization) assessed at four months.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Received same volume of saline

Group Type: PLACEBO_COMPARATOR

Control Saline

Intervention Type: DRUG

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

Darbepoetin group

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

Group Type: ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type: DRUG

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

Interventions

Darbepoetin alfa

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

Intervention Type: DRUG

Control Saline

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

Intervention Type: DRUG

Other Intervention Names

Nesp PFS Prefilled Syringe (Jeilkirin Pharm. Korea); 0.9% normal saline

Eligibility Criteria

Inclusion Criteria

• Patients with ST-elevation myocardial infarction (MI) within 12 hours of onset
• Suitable coronary anatomy for PCI
• Age < 80 yrs

Exclusion Criteria

• Uncontrolled congestive heart failure (Killip classes II and III, or cardiogenic shock)
• History of malignancy
• Serious hematological disease
• Current infectious disease requiring antibiotic therapy
• Baseline creatinine level > 2.0 mg/dL or dependence on dialysis
• Known hypersensitivity to or contraindication for heparin, aspirin, clopidogrel, sirolimus, everolimus, contrast medium and darbepoetin-α

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong-Ju Choi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-Ju Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Countries

South Korea

References

Suh JW, Yoon YE, Oh IY, Yoon CH, Cho YS, Youn TJ, Chae IH, Choi DJ. A single-center prospective randomized controlled trial evaluating the safety and efficacy of IntraCoronary Erythropoietin delivery BEfore Reperfusion: gauging infarct size in patients with acute ST-segment elevation myocardial infarction. Study design and rationale of the 'ICEBERG Trial'. Contemp Clin Trials. 2013 May;35(1):145-50. doi: 10.1016/j.cct.2013.03.001. Epub 2013 Mar 16.

Reference Type: DERIVED

PMID: 23506972 (View on PubMed)

Other Identifiers

DAMI

Identifier Type: -

Identifier Source: org_study_id