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

NCT ID: NCT01109134

Last Updated: 2010-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-08-31

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

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tirofiban intracoronary bolus-only

Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion

Group Type: EXPERIMENTAL

tirofiban intracoronary bolus-only

Intervention Type: DRUG

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

Tirofiban intravenous bolus+infusion

Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion

Group Type: ACTIVE_COMPARATOR

tirofiban intravenous bolus plus infusion

Intervention Type: DRUG

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

Interventions

tirofiban intracoronary bolus-only

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

Intervention Type: DRUG

tirofiban intravenous bolus plus infusion

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

Intervention Type: DRUG

Other Intervention Names

Aggrastat; Aggrastat

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Society of Cardiac Health Protection

UNKNOWN

Sponsor Role: collaborator

Kosuyolu Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kosuyolu Heart and Research Hospital

Principal Investigators

Cevat Kırma, Assoc.Prof

Role: STUDY_CHAIR

Kosuyolu Heart and Research Hospital

Ayhan Erkol, M.D

Role: PRINCIPAL_INVESTIGATOR

Kosuyolu Heart and Research Hospital

Other Identifiers

33

Identifier Type: -

Identifier Source: org_study_id