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Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital Identifier:
First received: February 16, 2010
Last updated: March 2, 2010
Last verified: March 2010
Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.

Condition Intervention Phase
Myocardial Infarction
Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • In cardiac MRI- infarct size (total late enhancement volume at day 3-7) [ Time Frame: day 3~7 after percutaneous coronary intervention ]
    MRI: magnetic resonance image

Secondary Outcome Measures:
  • in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc. [ Time Frame: 1 month ]
  • b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication. [ Time Frame: 1 month ]
    RBC: red blood cell

  • TIMI III flow count /myocardial blush score after PCI [ Time Frame: 1 day ]
    TIMI: thrombolysis in myocardial infarction PCI: percutaneous coronary intervention

  • At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index [ Time Frame: 1 week ]
    LV: left ventricle

  • Discharge, 1- month after comparing NT-proBNP [ Time Frame: 1 month ]
    NT-proBNP : N-terminal pro-B-Type natriuretic peptide

Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abciximab IC bolus
After CAG, For patients with undergoing percutaneous coronary intervention, intracoronary only or intravenous bolus abciximab(0.25mg/kg body weight) administration with intravenous bolus group has subsequent 12-hours continuous infusion at a dose 0.125ug/kg per minute (maximum: 10ug/min)
Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min)
Active Comparator: Abciximab IV bolus and 12hr continuous Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min)


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • non-ST segment elevation acute myocardial infarction
  • within 48 hours presence of chest pain
  • Troponin-T or I positive before CAG
  • First myocardial infarction
  • will be performed coronary angioplasty

Exclusion Criteria:

  • under 18 years of age,80 years or older
  • Bleeding tendency
  • History of major surgery within 4 weeks
  • Major stroke within 2 years
  • Thrombocytopenia (<120,000 / uL)
  • Cardiogenic shock
  • Known allergy to aspirin, heparin, or abciximab
  • Contraindication of MRI at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc)
  • Chronic atrial fibrillation
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01080638

Korea, Republic of
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Study Director: Hyun-Jae Kang, Prof Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital
  More Information

Responsible Party: Hyo-Soo Kim/ Prof, Director of Cardiac Catheterization Laboratory & Coronary Intervention of Seoul National University Hospital Identifier: NCT01080638     History of Changes
Other Study ID Numbers: H-0906-046-283 
Study First Received: February 16, 2010
Last Updated: March 2, 2010

Keywords provided by Seoul National University Hospital:
Myocardial Infarction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents processed this record on February 20, 2017