The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tirofiban
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Angioplasty, Transluminal, Percutaneous Coronary, tirofiban, Magnetic Resonance Imaging, Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage
Exclusion Criteria:
- hemodynamic instability
- history of MI
- old age > 80years
- Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose
Aspirin, clopidogrel, unfractionated heparin
Outcomes
Primary Outcome Measures
Infarct size and its transmural extent using MRI
Secondary Outcome Measures
pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography
Full Information
NCT ID
NCT00611169
First Posted
January 27, 2008
Last Updated
February 7, 2008
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00611169
Brief Title
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
Official Title
The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, tirofiban, Magnetic Resonance Imaging, Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose
Arm Title
2
Arm Type
No Intervention
Arm Description
Aspirin, clopidogrel, unfractionated heparin
Intervention Type
Drug
Intervention Name(s)
tirofiban
Intervention Description
tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
Primary Outcome Measure Information:
Title
Infarct size and its transmural extent using MRI
Time Frame
within the first 30 days after index procedure
Secondary Outcome Measure Information:
Title
pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography
Time Frame
at 6 month after index procedure
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:
presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage
Exclusion Criteria:
hemodynamic instability
history of MI
old age > 80years
Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
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