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

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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

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)

Trial contacts and locations

1

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Central trial contact

Myung-Ki Seo, MD; Hyun-Jae Kang, Prof

Data sourced from clinicaltrials.gov

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