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| Name | Class |
|---|---|
| The Society of Cardiac Health Protection | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirofiban intracoronary bolus-only | Experimental | Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion |
|
| Tirofiban intravenous bolus+infusion | Active Comparator | Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tirofiban intracoronary bolus-only | Drug | administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Indices of microvascular perfusion | Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve | Post-PCI day 4 to 5 |
| Measure | Description | Time Frame |
|---|---|---|
| ST segment resolution | post-PCI 90. minute | |
| corrected TIMI frame count | immediately after PCI, post-PCI day 4 to 5 | |
| Myocardial Blush Grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cevat Kırma, Assoc.Prof | Kosuyolu Heart and Research Hospital | Study Chair |
| Ayhan Erkol, M.D | Kosuyolu Heart and Research Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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|
| tirofiban intravenous bolus plus infusion | Drug | administer tirofiban bolus intravenously and maintain infusion for up to 18 hours |
|
|
| immediately after PCI, post-PCI day 4 to 5 |
| Scintigraphic infarct size | Left ventricular infarct size by SPECT | 6th month |
| Changes in left ventricular volume | Measured with echocardiography by using modified Simpson's method | Post-PCI day 3- 6th month |
| Composite of major adverse cardiovascular events | composite of reinfarction, target vessel revascularization and death. | 6 month |
| D000602 |
| Amino Acids, Peptides, and Proteins |