NCT01080638

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

February 16, 2010

Last Update Submit

April 22, 2026

Conditions

AngioplastyMyocardial Infarction

Keywords

abciximabMyocardial InfarctionangioplastyPlatelet

Outcome Measures

Primary Outcomes (1)

  • In cardiac MRI- infarct size (total late enhancement volume at day 3-7)

    MRI: magnetic resonance image

    day 3~7 after percutaneous coronary intervention

Secondary Outcomes (5)

  • in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc.

    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.

    1 month

  • TIMI III flow count /myocardial blush score after PCI

    1 day

  • At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index

    1 week

  • Discharge, 1- month after comparing NT-proBNP

    1 month

Study Arms (2)

Abciximab IC bolus

EXPERIMENTAL

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)

Abciximab IV bolus and 12hr continuous

ACTIVE COMPARATOR
Drug: glycoprotein IIb/IIIa inhibitor (abciximab)

Interventions

glycoprotein IIb/IIIa inhibitor (abciximab)DRUG

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)

Abciximab IC bolusAbciximab IV bolus and 12hr continuous

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Hyun-Jae Kang, Prof

    Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

February 16, 2010

First Posted

March 4, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

KR(1)