Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
Primary Purpose
Myocardial Infarction, Angioplasty
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
glycoprotein IIb/IIIa inhibitor (abciximab)
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring abciximab, Myocardial Infarction, angioplasty, Platelet
Eligibility Criteria
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
Sites / Locations
- Department of Internal Medicine, Cardiovascular Center, Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Abciximab IC bolus
Abciximab IV bolus and 12hr continuous
Arm 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)
Outcomes
Primary Outcome Measures
In cardiac MRI- infarct size (total late enhancement volume at day 3-7)
MRI: magnetic resonance image
Secondary Outcome Measures
in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc.
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
TIMI III flow count /myocardial blush score after PCI
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
LV: left ventricle
Discharge, 1- month after comparing NT-proBNP
NT-proBNP : N-terminal pro-B-Type natriuretic peptide
Full Information
NCT ID
NCT01080638
First Posted
February 16, 2010
Last Updated
March 2, 2010
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01080638
Brief Title
Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Angioplasty
Keywords
abciximab, Myocardial Infarction, angioplasty, Platelet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abciximab IC bolus
Arm Type
Experimental
Arm 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)
Arm Title
Abciximab IV bolus and 12hr continuous
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
glycoprotein IIb/IIIa inhibitor (abciximab)
Intervention Description
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)
Primary Outcome Measure Information:
Title
In cardiac MRI- infarct size (total late enhancement volume at day 3-7)
Description
MRI: magnetic resonance image
Time Frame
day 3~7 after percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
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
Title
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.
Description
RBC: red blood cell
Time Frame
1 month
Title
TIMI III flow count /myocardial blush score after PCI
Description
TIMI: thrombolysis in myocardial infarction PCI: percutaneous coronary intervention
Time Frame
1 day
Title
At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index
Description
LV: left ventricle
Time Frame
1 week
Title
Discharge, 1- month after comparing NT-proBNP
Description
NT-proBNP : N-terminal pro-B-Type natriuretic peptide
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ki Seo, MD
Phone
82-2-2072-3757
Email
clotinab@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Jae Kang, Prof
Phone
82-2-2072-2279
Email
nowkang@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Jae Kang, Prof
Organizational Affiliation
Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ki Seo, MD
Phone
82-2-2072-3757
Email
clotinab@gmail.com
First Name & Middle Initial & Last Name & Degree
Hyun-Jae Kang, Prof
Phone
82-2-2072-2279
Email
nowkang@snu.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
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