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Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109134
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : April 22, 2010
The Society of Cardiac Health Protection
Information provided by:
Kosuyolu Heart Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: tirofiban intracoronary bolus-only Drug: tirofiban intravenous bolus plus infusion Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Tirofiban

Arm Intervention/treatment
Experimental: Tirofiban intracoronary bolus-only
Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion
Drug: tirofiban intracoronary bolus-only
administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
Other Name: Aggrastat

Active Comparator: Tirofiban intravenous bolus+infusion
Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion
Drug: tirofiban intravenous bolus plus infusion
administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
Other Name: Aggrastat

Primary Outcome Measures :
  1. Indices of microvascular perfusion [ Time Frame: Post-PCI day 4 to 5 ]
    Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve

Secondary Outcome Measures :
  1. ST segment resolution [ Time Frame: post-PCI 90. minute ]
  2. corrected TIMI frame count [ Time Frame: immediately after PCI, post-PCI day 4 to 5 ]
  3. Myocardial Blush Grade [ Time Frame: immediately after PCI, post-PCI day 4 to 5 ]
  4. Scintigraphic infarct size [ Time Frame: 6th month ]
    Left ventricular infarct size by SPECT

  5. Changes in left ventricular volume [ Time Frame: Post-PCI day 3- 6th month ]
    Measured with echocardiography by using modified Simpson's method

  6. Composite of major adverse cardiovascular events [ Time Frame: 6 month ]
    composite of reinfarction, target vessel revascularization and death.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01109134

Sponsors and Collaborators
Kosuyolu Heart Hospital
The Society of Cardiac Health Protection
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Study Chair: Cevat Kırma, Assoc.Prof Kosuyolu Heart and Research Hospital
Principal Investigator: Ayhan Erkol, M.D Kosuyolu Heart and Research Hospital
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Responsible Party: Cevat KIRMA, Kosuyolu Heart and Research Hospital Identifier: NCT01109134    
Other Study ID Numbers: 33
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: April 22, 2010
Last Verified: March 2010
Keywords provided by Kosuyolu Heart Hospital:
primary angioplasty
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors