tirofiban intracoronary bolus-only
Drugadminister tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
Other names: Aggrastat
NCT Number: NCT01109134
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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Notify Me25 year–75 year
All sexes
Interventional
Phase 3
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
Other names: Aggrastat
administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
Other names: Aggrastat
Time frame: Post-PCI day 4 to 5
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve
Time frame: post-PCI 90. minute
Time frame: immediately after PCI, post-PCI day 4 to 5
Time frame: immediately after PCI, post-PCI day 4 to 5
Time frame: 6th month
Left ventricular infarct size by SPECT
Time frame: Post-PCI day 3- 6th month
Measured with echocardiography by using modified Simpson's method
Time frame: 6 month
composite of reinfarction, target vessel revascularization and death.
Kosuyolu Heart Hospital
Other
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
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