DRUG
Short Tirofiban
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.
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
Status
Completed
Phase
Phase 2
Enrollment
535
Locations
13
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Eptifibatide
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.
DRUG
Long Tirofiban
25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
Timeline
From registration to results.
First posted
Jan 31, 2012
Study start
Apr 2012
Primary completion
Dec 2018
Study completion
Mar 2019
Results posted
Apr 20, 2021
Registry updated
May 13, 2021
Outcomes
What the study measures.
Primary outcomes
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding
Time frame · 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 outcomes
The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
13 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Osceola Regional Medical Center
Kissimmee, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
North Georgia Heart Center
Gainesville, Georgia, United States
Redmond Regional Medical Center
Rome, 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
Doylestown Hospital
Doylestown, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Centennial Heart
Nashville, Tennessee, United States
Chippenham Hospital
Richmond, Virginia, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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