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

Phase 4

• Conditions: Myocardial Infarction; Angioplasty
• Interventions: Drug: glycoprotein IIb/IIIa inhibitor (abciximab)

• Registration Number: NCT01080638
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-16
• Status Verified: 2010-03
• Study First Submitted QC: 2010-03-02
• Last Update Submitted: 2010-03-02
• Study First Posted: 2010-03-04
• Last Update Posted: 2010-03-04
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abciximab IC bolus	glycoprotein IIb/IIIa inhibitor (abciximab)	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)
Abciximab IV bolus and 12hr continuous	glycoprotein IIb/IIIa inhibitor (abciximab)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of