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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Angioplasty; Myocardial Infarction

Treatments: Drug: glycoprotein IIb/IIIa inhibitor (abciximab)

Study type: Interventional

Funder types: Other

Identifiers

NCT01080638

H-0906-046-283

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Abciximab IC bolus

Experimental group

Description:

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)

Treatment:

Drug: glycoprotein IIb/IIIa inhibitor (abciximab)

Abciximab IV bolus and 12hr continuous

Active Comparator group

Treatment:

Drug: glycoprotein IIb/IIIa inhibitor (abciximab)