NCT01522417

Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

A Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy of Tirofiban Using a High-Dose Bolus Plus a Shortened Infusion Duration Versus Label-Dosing Eptifibatide in Patients Undergoing Percutaneous Coronary Intervention

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 535 (actual)
• Sponsor: Medicure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• Acute Coronary Syndromes
• Unstable Angina

Interventions

Type	Name	Description
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.
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

• Start date: 2012-04-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2012-01-31
• Last updated: 2021-05-13
• Results posted: 2021-04-20

Locations

13 sites across 1 country: United States