Clinical trial NCT01109134: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Keywords: primary angioplasty
tirofiban
microcirculation
Lead sponsor: Kosuyolu Heart Hospital
Sponsor class: OTHER
Collaborators: name: The Society of Cardiac Health Protection
First posted: 2010-04-22
Enrollment: 49
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Indices of microvascular perfusion
timeFrame: Post-PCI day 4 to 5
Secondary outcomes:
measure: ST segment resolution
timeFrame: post-PCI 90. minute
measure: corrected TIMI frame count
timeFrame: immediately after PCI, post-PCI day 4 to 5
measure: Myocardial Blush Grade
timeFrame: immediately after PCI, post-PCI day 4 to 5
measure: Scintigraphic infarct size
timeFrame: 6th month
measure: Changes in left ventricular volume
timeFrame: Post-PCI day 3- 6th month
measure: Composite of major adverse cardiovascular events
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Kosuyolu Heart and Research Hospital
name: Cevat Kırma, Assoc.Prof
role: STUDY_CHAIR
affiliation: Kosuyolu Heart and Research Hospital
name: Ayhan Erkol, M.D
role: PRINCIPAL_INVESTIGATOR
References: