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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01080638
First received: February 16, 2010
Last updated: March 2, 2010
Last verified: March 2010

February 16, 2010
March 2, 2010
October 2009
December 2010   (final data collection date for primary outcome measure)
In cardiac MRI- infarct size (total late enhancement volume at day 3-7) [ Time Frame: day 3~7 after percutaneous coronary intervention ] [ Designated as safety issue: No ]
MRI: magnetic resonance image
Same as current
Complete list of historical versions of study NCT01080638 on ClinicalTrials.gov Archive Site
  • in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    RBC: red blood cell
  • TIMI III flow count /myocardial blush score after PCI [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    LV: left ventricle
  • Discharge, 1- month after comparing NT-proBNP [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    NT-proBNP : N-terminal pro-B-Type natriuretic peptide
Same as current
Not Provided
Not Provided
 
Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Angioplasty
Drug: 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)
  • Experimental: 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)
    Intervention: Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
  • Active Comparator: Abciximab IV bolus and 12hr continuous
    Intervention: Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Myung-Ki Seo, MD 82-2-2072-3757 clotinab@gmail.com
Contact: Hyun-Jae Kang, Prof 82-2-2072-2279 nowkang@snu.ac.kr
Korea, Republic of
 
NCT01080638
H-0906-046-283
Yes
Hyo-Soo Kim/ Prof, Director of Cardiac Catheterization Laboratory & Coronary Intervention of Seoul National University Hospital
Seoul National University Hospital
Seoul National University Bundang Hospital
Study Director: Hyun-Jae Kang, Prof Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital
Seoul National University Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP