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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109134
• Other study ID #: 33
• Status: Completed
• Phase: Phase 3
• First received: April 21, 2010
• Last updated: April 21, 2010
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2010
• Source: Kosuyolu Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• tirofiban intracoronary bolus-only
administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
• tirofiban intravenous bolus plus infusion
administer tirofiban bolus intravenously and maintain infusion for up to 18 hours

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kosuyolu Heart Hospital	The Society of Cardiac Health Protection

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indices of microvascular perfusion	Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve	Post-PCI day 4 to 5	No
Secondary	ST segment resolution		post-PCI 90. minute	No
Secondary	corrected TIMI frame count		immediately after PCI, post-PCI day 4 to 5	No
Secondary	Myocardial Blush Grade		immediately after PCI, post-PCI day 4 to 5	No
Secondary	Scintigraphic infarct size	Left ventricular infarct size by SPECT	6th month	No
Secondary	Changes in left ventricular volume	Measured with echocardiography by using modified Simpson's method	Post-PCI day 3- 6th month	No
Secondary	Composite of major adverse cardiovascular events	composite of reinfarction, target vessel revascularization and death.	6 month	No