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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Unstable Angina; Acute Coronary Syndromes
• Intervention / Treatment: Drug: Short Tirofiban; Drug: Eptifibatide; Drug: Long Tirofiban

• Study Type: Interventional
• Enrollment (Actual): 535
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Osceola Regional Medical Center
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Gainesville, Georgia, United States, 30501
      • North Georgia Heart Center
    • Rome, Georgia, United States, 30165
      • Redmond Regional Medical Center
    • Thomasville, Georgia, United States, 31792
      • Archbold Medical Center
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Chippenham Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.; Other Names: Aggrastat
Active Comparator: 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).	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.; Other Names: Integrilin
Experimental: 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).	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.; Other Names: Aggrastat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding	The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.	48 hours or hospital discharge, whichever came first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Composite Endpoint of Death, Periprocedural Myonecrosis or Urgent Target Vessel Revascularization	The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 3 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), or urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia)	48 hours or hospital discharge, whichever came first
Individual Components of Death, Urgent Target Revascularization or Major Bleeding	Individual components of death (any-cause), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 major bleeding criteria.	48 hours or hospital discharge, whichever came first
Individual Components of Periprocedural Myonecrosis	Individual components of periprocedural myonecrosis (PPM) (defined as ≥ 3 times, ≥ 10 times, ≥ 20 times or ≥ 50 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value)	48 hours or hospital discharge, whichever came first
The Composite Endpoint of Death, Periprocedural Myonecrosis (PPM) (≥ 10x Troponin), Urgent Target Vessel Revascularization (uTVR) or Major Bleeding	The composite of death (any-cause), periprocedural myonecrosis (defined as ≥ 10 times the upper limit of normal troponin and at least 20% or greater than the baseline troponin value), urgent target revascularization (repeat PCI or any CABG procedure after the index PCI on a non-selective basis in the target vessel because of recurrent myocardial ischemia) or non-CABG related major bleeding as quantified according to REPLACE-2 bleeding criteria.	48 hours or hospital discharge, whichever came first

Collaborators and Investigators

• Sponsor: Medicure
• Collaborators: SCRI Development Innovations, LLC
• Investigators: Principal Investigator: Steven V Manoukian, MD, SCRI Development Innovations, LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): January 31, 2012

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Acute Coronary Syndrome; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban; Eptifibatide
• Other Study ID Numbers: Medicure 11002