Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

Phase 2

Completed

• Conditions: Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina
• Interventions: Drug: Eptifibatide; Drug: Long Tirofiban; Drug: Short Tirofiban

• Registration Number: NCT01522417
• Lead Sponsor: Medicure

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Study Start: 2012-04
• Primary Completion: 2018-12
• Study Completion: 2019-03
• Results First Submitted: 2021-03-25
• Results First Submitted QC: 2021-03-25
• Status Verified: 2021-04
• Results First Posted: 2021-04-20
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eptifibatide (Integrilin)	Eptifibatide	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).
Long Tirofiban (Aggrastat)	Long Tirofiban	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).
Short Tirofiban (Aggrastat)	Short Tirofiban	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).

Primary Outcome Measures

Name	Time	Method
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding	48 hours or hospital discharge, whichever came first	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.

Secondary Outcome Measures

Name	Time	Method
The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization	48 hours or hospital discharge, whichever came first	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)
Individual Components of Death, Urgent Target Revascularization or Major Bleeding	48 hours or hospital discharge, whichever came first	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.
Individual Components of Periprocedural Myonecrosis	48 hours or hospital discharge, whichever came first	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)
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding	48 hours or hospital discharge, whichever came first	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.

Trial Locations

Locations (13)

Doylestown Hospital; 🇺🇸 Doylestown, Pennsylvania, United States

Redmond Regional Medical Center; 🇺🇸 Rome, Georgia, United States

Osceola Regional Medical Center; 🇺🇸 Kissimmee, Florida, United States

Northside Hospital; 🇺🇸 Saint Petersburg, Florida, United States

North Georgia Heart Center; 🇺🇸 Gainesville, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Archbold Medical Center; 🇺🇸 Thomasville, Georgia, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Centennial Heart; 🇺🇸 Nashville, Tennessee, United States

Chippenham Hospital; 🇺🇸 Richmond, Virginia, United States