Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of death, PCI-related myocardial infarction, urgent target vessel revascularization or in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever comes first.

Official Title
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A Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy of Tirofiban Using a High-Dose Bolus Plus a Shortened Infusion Duration Versus Label-Dosing Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndromes, Myocardial Infarction, Unstable Angina

Intervention / Treatment
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* Drug: Short Tirofiban
* Drug: Eptifibatide
* Drug: Long Tirofiban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years of age Scheduled to undergo PCI with an FDA, approved or cleared device (stent or procedures such as balloon angioplasty, rotoblation, AngioSculpt, laser atherectomy,etc.) in one or more native coronary target lesions Written informed consent Exclusion Criteria: Primary PCI for STEMI as index procedure Prior STEMI within 48 hours before randomization Prior PCI within 30 days before randomization Planned staged PCI within the subsequent 24 hours after index PCI Use of abciximab within 7 days before randomization Use of tirofiban or eptifibatide within 12 hours before randomization Use of low-molecular weight heparin within 12 hours before randomization Use of bivalirudin within 12 hours before randomization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Tirofiban (Aggrastat)<br>Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). | Drug: Short Tirofiban<br>* 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.<br>* Other names: Aggrastat;|
| Active Comparator: Eptifibatide (Integrilin)<br>Eptifibatide (Integrilin) will be dosed as a 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first. Patients will receive eptifibatide (Integrilin) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). | Drug: Eptifibatide<br>* 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.<br>* Other names: Integrilin;|
| Experimental: Long Tirofiban (Aggrastat)<br>Tirofiban (Aggrastat) will be dosed as a 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post PCI. Patients will receive tirofiban (Aggrastat) on a background of dual oral anti-platelet agents and unfractionated heparin (50 U/kg and repeat dosing per protocol guidelines). | Drug: Long Tirofiban<br>* 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.<br>* Other names: Aggrastat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. | 48 hours or hospital discharge, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) | 48 hours or hospital discharge, whichever came first | 
| Individual Components of Death, Urgent Target Revascularization or Major Bleeding | Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria. | 48 hours or hospital discharge, whichever came first | 
| Individual Components of Periprocedural Myonecrosis | Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value) | 48 hours or hospital discharge, whichever came first | 
| The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding | The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria. | 48 hours or hospital discharge, whichever came first |