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

Study Overview
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Brief Summary
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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.

Conditions
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Myocardial Infarction, Angioplasty

Intervention / Treatment
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* Drug: glycoprotein IIb/IIIa inhibitor (abciximab)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abciximab IC bolus<br>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)<br>* 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)<br>|
| Active Comparator: Abciximab IV bolus and 12hr continuous<br> | Drug: glycoprotein IIb/IIIa inhibitor (abciximab)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abciximab, Myocardial Infarction, angioplasty, Platelet