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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01109134
Enrollment
49
Registered
2010-04-22
Start date
2008-09-30
Completion date
2009-08-31
Last updated
2010-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

primary angioplasty, tirofiban, microcirculation

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

Interventions

DRUGtirofiban intracoronary bolus-only

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

DRUGtirofiban intravenous bolus plus infusion

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

Sponsors

The Society of Cardiac Health Protection
CollaboratorUNKNOWN
Kosuyolu Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Indices of microvascular perfusionPost-PCI day 4 to 5Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve

Secondary

MeasureTime frameDescription
corrected TIMI frame countimmediately after PCI, post-PCI day 4 to 5
Myocardial Blush Gradeimmediately after PCI, post-PCI day 4 to 5
Scintigraphic infarct size6th monthLeft ventricular infarct size by SPECT
Changes in left ventricular volumePost-PCI day 3- 6th monthMeasured with echocardiography by using modified Simpson's method
Composite of major adverse cardiovascular events6 monthcomposite of reinfarction, target vessel revascularization and death.
ST segment resolutionpost-PCI 90. minute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026