Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

Completed · Phase 2

Conditions studied: Myocardial Infarction, Acute Coronary Syndromes, Unstable Angina

In brief

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.

Key facts

Study ID

NCT01522417

Run by

Medicure

People needed

535

Starts

2012-04-01

Expected to finish

2019-03-01

Last updated by the study team

2021-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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