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

April 22, 2026 updated by: Hyo-Soo Kim, Seoul National University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 3~7 after percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
1 month
TIMI III flow count /myocardial blush score after PCI
Time Frame: 1 day
TIMI: thrombolysis in myocardial infarction PCI: percutaneous coronary intervention
1 day
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
1 week
Discharge, 1- month after comparing NT-proBNP
Time Frame: 1 month
NT-proBNP : N-terminal pro-B-Type natriuretic peptide
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital

Investigators

  • Study Director: Hyun-Jae Kang, Prof, Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimated)

March 4, 2010

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-0906-046-283

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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