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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
Kosuyolu Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring primary angioplasty, tirofiban, microcirculation

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 21, 2010
    Last Updated
    April 21, 2010
    Sponsor
    Kosuyolu Heart Hospital
    Collaborators
    The Society of Cardiac Health Protection
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    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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