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

This study has been completed.
Sponsor:
Collaborator:
The Society of Cardiac Health Protection
Information provided by:
Kosuyolu Heart Hospital
ClinicalTrials.gov Identifier:
NCT01109134
First received: April 21, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Drug: tirofiban intracoronary bolus-only
Drug: tirofiban intravenous bolus plus infusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kosuyolu Heart Hospital:

Primary Outcome Measures:
  • Indices of microvascular perfusion [ Time Frame: Post-PCI day 4 to 5 ] [ Designated as safety issue: No ]
    Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve


Secondary Outcome Measures:
  • ST segment resolution [ Time Frame: post-PCI 90. minute ] [ Designated as safety issue: No ]
  • corrected TIMI frame count [ Time Frame: immediately after PCI, post-PCI day 4 to 5 ] [ Designated as safety issue: No ]
  • Myocardial Blush Grade [ Time Frame: immediately after PCI, post-PCI day 4 to 5 ] [ Designated as safety issue: No ]
  • Scintigraphic infarct size [ Time Frame: 6th month ] [ Designated as safety issue: No ]
    Left ventricular infarct size by SPECT

  • Changes in left ventricular volume [ Time Frame: Post-PCI day 3- 6th month ] [ Designated as safety issue: No ]
    Measured with echocardiography by using modified Simpson's method

  • Composite of major adverse cardiovascular events [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    composite of reinfarction, target vessel revascularization and death.


Enrollment: 49
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Aggrastat

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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109134

Sponsors and Collaborators
Kosuyolu Heart Hospital
The Society of Cardiac Health Protection
Investigators
Study Chair: Cevat Kırma, Assoc.Prof Kosuyolu Heart and Research Hospital
Principal Investigator: Ayhan Erkol, M.D Kosuyolu Heart and Research Hospital
  More Information

No publications provided

Responsible Party: Cevat KIRMA, Kosuyolu Heart and Research Hospital
ClinicalTrials.gov Identifier: NCT01109134     History of Changes
Other Study ID Numbers: 33
Study First Received: April 21, 2010
Last Updated: April 21, 2010
Health Authority: Turkey: Ethics Committee

Keywords provided by Kosuyolu Heart Hospital:
primary angioplasty
tirofiban
microcirculation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014