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

Sponsor

Kosuyolu Heart Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01109134

Collaborator

The Society of Cardiac Health Protection (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Sep 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

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 Names: 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 Names: Aggrastat

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 Names:

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 Names:

Aggrastat

Outcome Measures

Primary Outcome Measures

Indices of microvascular perfusion [Post-PCI day 4 to 5]
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve

Secondary Outcome Measures

ST segment resolution [post-PCI 90. minute]
corrected TIMI frame count [immediately after PCI, post-PCI day 4 to 5]
Myocardial Blush Grade [immediately after PCI, post-PCI day 4 to 5]
Scintigraphic infarct size [6th month]
Left ventricular infarct size by SPECT
Changes in left ventricular volume [Post-PCI day 3- 6th month]
Measured with echocardiography by using modified Simpson's method
Composite of major adverse cardiovascular events [6 month]
composite of reinfarction, target vessel revascularization and death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.