Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

Myocardial Infarction Clinical Trial

— SAVI-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522417
• Other study ID #: Medicure 11002
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: March 2019

Study information

• Verified date: April 2021
• Source: Medicure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Unstable Angina

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	North Georgia Heart Center	Gainesville	Georgia
United States	Osceola Regional Medical Center	Kissimmee	Florida
United States	Centennial Heart	Nashville	Tennessee
United States	Lenox Hill Hospital	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Chippenham Hospital	Richmond	Virginia
United States	Redmond Regional Medical Center	Rome	Georgia
United States	Northside Hospital	Saint Petersburg	Florida
United States	Archbold Medical Center	Thomasville	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Medicure	SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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