Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention (SAVI-PCI)

Medicure

Status and phase: Completed; Phase 2

Conditions: Unstable Angina; Acute Coronary Syndromes; Myocardial Infarction

Treatments: Drug: Long Tirofiban; Drug: Short Tirofiban; Drug: Eptifibatide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01522417

Medicure 11002

Details and patient eligibility

About

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.

Enrollment: 535 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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535 participants in 3 patient groups

Short Tirofiban (Aggrastat)

Experimental group

Description:

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).

Treatment:

Drug: Short Tirofiban

Eptifibatide (Integrilin)

Active Comparator group

Description:

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).

Treatment:

Drug: Eptifibatide

Long Tirofiban (Aggrastat)

Experimental group

Description:

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).

Treatment:

Drug: Long Tirofiban