Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
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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 |
- 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
- 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 |
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| 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 May 19, 2013