Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
NCT ID: NCT01522417
Last Updated: 2021-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
535 participants
INTERVENTIONAL
2012-04-30
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short Tirofiban (Aggrastat)
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).
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.
Eptifibatide (Integrilin)
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).
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.
Long Tirofiban (Aggrastat)
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).
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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SCRI Development Innovations, LLC
OTHER
Medicure
INDUSTRY
Responsible Party
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Principal Investigators
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Steven V Manoukian, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Medicure 11002
Identifier Type: -
Identifier Source: org_study_id
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