Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
tirofiban intracoronary bolus-only
tirofiban intravenous bolus plus infusion
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring primary angioplasty, tirofiban, microcirculation
Eligibility Criteria
Inclusion Criteria:
- Typical ongoing ischemic chest pain for longer than 30 minutes
- ST segment elevation of 0,1 mV or greater in at least two contiguous leads or a new left bundle branch block on the initial ECG.
Exclusion Criteria:
- Cardiogenic shock and / or clinical instability
- previous STEMI
- Malignant life threatening diseases
- Presence of an additional lesion causing more than 50% narrowing distal to the culprit lesion
- Contraindications to aspirin, clopidogrel, or heparin
- inability to give informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tirofiban intracoronary bolus-only
Tirofiban intravenous bolus+infusion
Arm Description
Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion
Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion
Outcomes
Primary Outcome Measures
Indices of microvascular perfusion
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve
Secondary Outcome Measures
ST segment resolution
corrected TIMI frame count
Myocardial Blush Grade
Scintigraphic infarct size
Left ventricular infarct size by SPECT
Changes in left ventricular volume
Measured with echocardiography by using modified Simpson's method
Composite of major adverse cardiovascular events
composite of reinfarction, target vessel revascularization and death.
Full Information
NCT ID
NCT01109134
First Posted
April 21, 2010
Last Updated
April 21, 2010
Sponsor
Kosuyolu Heart Hospital
Collaborators
The Society of Cardiac Health Protection
1. Study Identification
Unique Protocol Identification Number
NCT01109134
Brief Title
Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
Official Title
Prospective Randomized Controlled Clinical Study to Compare Tirofiban Intracoronary Bolus-Only vs Intravenous Bolus Plus Infusion in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kosuyolu Heart Hospital
Collaborators
The Society of Cardiac Health Protection
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.
Detailed Description
Primary percutaneous coronary intervention (PCI) is currently the treatment of choice for patients with acute ST elevation myocardial infarction (STEMI). Nevertheless, despite restoration of normal epicardial flow, myocardial perfusion remains impaired in approximately half of patients and is associated with a poor prognosis. A variety of invasive and non-invasive techniques have been proposed to evaluate microvascular perfusion and several invasive hemodynamic measures have been closely associated with microvascular damage.In order to improve microvascular perfusion after primary PCI, a variety of treatment strategies have been developed, such as adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPIs). Although current ACC/AHA guidelines recommend that small molecule GPIs should be administered as a bolus followed by 18 hours of continuous infusion, changes in clinical practice may obviate the need for a maintenance infusion in current practice.
We hypothesized that when tirofiban is administered via intracoronary route, a bolus-only strategy may even be superior to intravenous bolus plus infusion strategy in maintaining myocardial perfusion. In order to evaluate microvascular function, we used a guidewire tipped with pressure and temperature sensors and measured the coronary hemodynamic parameters, as the index of microvascular resistance and coronary flow reserve, measures which have been closely associated with microvascular damage. In order to increase the predictive value of these indices, we performed these measurements four to five days after MI, because it has been shown that the extent of microvascular dysfunction changes, particularly within first 48 hours after reperfusion and stabilizes between 2 days and 1 week after perfusion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
primary angioplasty, tirofiban, microcirculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tirofiban intracoronary bolus-only
Arm Type
Experimental
Arm Description
Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion
Arm Title
Tirofiban intravenous bolus+infusion
Arm Type
Active Comparator
Arm Description
Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion
Intervention Type
Drug
Intervention Name(s)
tirofiban intracoronary bolus-only
Other Intervention Name(s)
Aggrastat
Intervention Description
administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
Intervention Type
Drug
Intervention Name(s)
tirofiban intravenous bolus plus infusion
Other Intervention Name(s)
Aggrastat
Intervention Description
administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
Primary Outcome Measure Information:
Title
Indices of microvascular perfusion
Description
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve
Time Frame
Post-PCI day 4 to 5
Secondary Outcome Measure Information:
Title
ST segment resolution
Time Frame
post-PCI 90. minute
Title
corrected TIMI frame count
Time Frame
immediately after PCI, post-PCI day 4 to 5
Title
Myocardial Blush Grade
Time Frame
immediately after PCI, post-PCI day 4 to 5
Title
Scintigraphic infarct size
Description
Left ventricular infarct size by SPECT
Time Frame
6th month
Title
Changes in left ventricular volume
Description
Measured with echocardiography by using modified Simpson's method
Time Frame
Post-PCI day 3- 6th month
Title
Composite of major adverse cardiovascular events
Description
composite of reinfarction, target vessel revascularization and death.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Typical ongoing ischemic chest pain for longer than 30 minutes
ST segment elevation of 0,1 mV or greater in at least two contiguous leads or a new left bundle branch block on the initial ECG.
Exclusion Criteria:
Cardiogenic shock and / or clinical instability
previous STEMI
Malignant life threatening diseases
Presence of an additional lesion causing more than 50% narrowing distal to the culprit lesion
Contraindications to aspirin, clopidogrel, or heparin
inability to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cevat Kırma, Assoc.Prof
Organizational Affiliation
Kosuyolu Heart and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ayhan Erkol, M.D
Organizational Affiliation
Kosuyolu Heart and Research Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
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