- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01109134
Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tirofiban intracoronary bolus-only
Tirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion
|
administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
Other Names:
|
Active Comparator: Tirofiban intravenous bolus+infusion
Tirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion
|
administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indices of microvascular perfusion
Time Frame: Post-PCI day 4 to 5
|
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve
|
Post-PCI day 4 to 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ST segment resolution
Time Frame: post-PCI 90. minute
|
post-PCI 90. minute
|
|
corrected TIMI frame count
Time Frame: immediately after PCI, post-PCI day 4 to 5
|
immediately after PCI, post-PCI day 4 to 5
|
|
Myocardial Blush Grade
Time Frame: immediately after PCI, post-PCI day 4 to 5
|
immediately after PCI, post-PCI day 4 to 5
|
|
Scintigraphic infarct size
Time Frame: 6th month
|
Left ventricular infarct size by SPECT
|
6th month
|
Changes in left ventricular volume
Time Frame: Post-PCI day 3- 6th month
|
Measured with echocardiography by using modified Simpson's method
|
Post-PCI day 3- 6th month
|
Composite of major adverse cardiovascular events
Time Frame: 6 month
|
composite of reinfarction, target vessel revascularization and death.
|
6 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Cevat Kırma, Assoc.Prof, Kosuyolu Heart and Research Hospital
- Principal Investigator: Ayhan Erkol, M.D, Kosuyolu Heart and Research Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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