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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01080638

Enrollment

150

Registered

2010-03-04

Start date

2009-08-01

Completion date

2012-12-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Myocardial Infarction

Keywords

abciximab, Myocardial Infarction, angioplasty, Platelet

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.

Interventions

DRUGglycoprotein 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
In cardiac MRI- infarct size (total late enhancement volume at day 3-7)	day 3~7 after percutaneous coronary intervention	MRI: magnetic resonance image

Secondary

Measure	Time frame	Description
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	RBC: red blood cell
TIMI III flow count /myocardial blush score after PCI	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	1 week	LV: left ventricle
Discharge, 1- month after comparing NT-proBNP	1 month	NT-proBNP : N-terminal pro-B-Type natriuretic peptide

Countries

South Korea

Contacts

STUDY_DIRECTORHyun-Jae Kang, Prof

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026