Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicure
• Collaborator: SCRI Development Innovations, LLC
• Treatments: Eptifibatide; Tirofiban

Criteria

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