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

NCT ID: NCT01080638

Last Updated: 2010-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

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.

Detailed Description

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Conditions

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Myocardial Infarction Angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Abciximab IC bolus

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)

Group Type EXPERIMENTAL

glycoprotein IIb/IIIa inhibitor (abciximab)

Intervention Type DRUG

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)

Abciximab IV bolus and 12hr continuous

Group Type ACTIVE_COMPARATOR

glycoprotein IIb/IIIa inhibitor (abciximab)

Intervention Type DRUG

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)

Interventions

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glycoprotein 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)

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Director of Cardiac Catheterization Laboratory & Coronary Intervention of Seoul National University Hospital

Principal Investigators

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Hyun-Jae Kang, Prof

Role: STUDY_DIRECTOR

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

Locations

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Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myung-Ki Seo, MD

Role: CONTACT

82-2-2072-3757

Hyun-Jae Kang, Prof

Role: CONTACT

82-2-2072-2279

Facility Contacts

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Myung-Ki Seo, MD

Role: primary

82-2-2072-3757

Hyun-Jae Kang, Prof

Role: backup

82-2-2072-2279

Other Identifiers

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H-0906-046-283

Identifier Type: -

Identifier Source: org_study_id

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