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Completed

NCT Number: NCT01109134

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

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tirofiban intracoronary bolus-only

Drug

administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion

Other names: Aggrastat

tirofiban intravenous bolus plus infusion

Drug

administer tirofiban bolus intravenously and maintain infusion for up to 18 hours

Other names: Aggrastat

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kosuyolu Heart Hospital

Other

Collaborators

  • The Society of Cardiac Health Protection

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2010
Registry last updated
Apr 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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