Text Size

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

This study is currently recruiting participants.
Verified July 2012 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01538771
First received: February 15, 2012
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

Prospective, randomized and open label trial

Hypothesis

  • Infusion of intracoronary darbepoetin-alpha at primary percutaneous coronary intervention (PCI) may reduce infarct size and post-infarct remodeling.

Methods

  • Randomization into control group or treatment group
  • Treatment group : Darbepoetin-alpha 300ug intracoronary bolus infusion via over-the-wire balloon system before 1st ballooning 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 volume and area at risk
  • MRI at 4 months : prevalence of post-infarct remodeling (definition: increase of end-diastolic volume index > 20% compared to baseline)
  • safety endpoint : cardiac death, nonfatal MI, stroke, readmission due to heart failure or ischemic symptom, urgent target lesion revascularization

Condition Intervention Phase
Acute Myocardial Infarction
 Drug: Darbepoetin alfa
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect and Safety of Intracoronary Darbepoetin-alpha On the Infarct Size and Post-Infarct Remodeling in Primary Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Peak CK-MB/ Troponin-I levels [ Time Frame: baseline, 6, 12,18,24,36,48hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infarct size [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days ] [ Designated as safety issue: No ]
    Assessed by cardiac MRI

  • Post-infarct remodeling assessed by cardiac MRI [ Time Frame: 4months ] [ Designated as safety issue: No ]
    Definition : Increase of end-diastolic volume of left ventricle >20%

  • Composites of cardiovascular endpoints [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]
    cardiac death, nonfatal MI, ischemic stroke, readmission d/t heart failure or ischemic symptom, target lesion revascularization


Estimated Enrollment: 80
Study Start Date: November 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control Drug: Placebo
conventional treatment
Active Comparator: Darbepoetin Treatment
Darbepoetin 300ug intracoronary infusion before 1st ballooning
 Drug: Darbepoetin alfa
Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning & conventional treatment
Other Name: Nesp PFS Prefilled Syringe (Jeilkirin Pharm. Korea)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous history of MI
  • Cardiogenic shock
  • Increased hemoglobin level (> 17g/dL)
  • Uncontrolled hypertension
  • History of arterial or venous thrombosis or ischemic stroke
  • Patients with valvular heart disease
  • Decreased renal function (Cr > 2.0mg/dL) or hepatic function (Child B or C liver cirrhosis)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538771

Contacts
Contact: Dong-Ju Choi, MD, PhD 82-31-787-7007 djchoi@snubh.org
Contact: Jung-Won Suh, MD, PhD 82-31-787-7016 suhjw1@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463707
Contact: Dong-Ju Choi, MD, PhD     82-31-787-7007     djchoi@snubh.org    
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Dong-Ju Choi, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Dong-Ju Choi, Principal Investigator, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01538771     History of Changes
Other Study ID Numbers: DAMI
Study First Received: February 15, 2012
Last Updated: July 31, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
acute myocardial infarction
erythropoietin
reperfusion injury
ventricular remodeling

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013