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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina	Drug: Short Tirofiban; Drug: Eptifibatide; Drug: Long Tirofiban	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	550 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	April 2012
Estimated Primary Completion Date :	March 2019
Estimated Study Completion Date :	July 2019

Arms and Interventions

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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 Name: 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 Name: Integrilin
Experimental: Long Tirofiban (Aggrastat); (Enrolment Completed) Tirofiban (Aggrastat) will be dosed as a 25 ug/kg i.v. bolus followed by a 0.15 ug/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 (50U/kg and repeat dosing per protocol guidelines).	Drug: Long Tirofiban; 25 ug/kg i.v. bolus followed by a 0.15 ug/kg/min i.v. infusion for 12 to 18 hours post-PCI.; Other Name: Aggrastat

Outcome Measures

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Primary Outcome Measures :

1. The composite incidence of death, PCI-related myocardial infarction, urgent target vessel revascularization or major bleeding [ Time Frame: 48 hours ]

Secondary Outcome Measures :

1. The composite incidence of death, PCI-related myocardial infarction or urgent target vessel revascularization [ Time Frame: 48 hours ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Debbie Douglas, PhD	204-594-3624	ddouglas@medicure.com

Locations

United States, Florida
Osceola Regional Medical Center	Completed
Kissimmee, Florida, United States, 34741
Northside Hospital	Completed
Saint Petersburg, Florida, United States, 33709
United States, Georgia
Emory University Hospital Midtown	Completed
Atlanta, Georgia, United States, 30308
Emory University Hospital	Completed
Atlanta, Georgia, United States, 30322
North Georgia Heart Center	Completed
Gainesville, Georgia, United States, 30501
Redmond Regional Medical Center	Recruiting
Rome, Georgia, United States, 30165
Principal Investigator: Hector R Picon, MD
Archbold Medical Center	Completed
Thomasville, Georgia, United States, 31792
United States, New York
Lenox Hill Hospital	Completed
New York, New York, United States, 10075
United States, Oklahoma
University of Oklahoma Health Sciences Center	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Mazen Abu-Fadel, MD
United States, Pennsylvania
Doylestown Hospital	Completed
Doylestown, Pennsylvania, United States, 18901
Penn Presbyterian Medical Center	Completed
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Centennial Heart	Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Brian K Jefferson, MD
United States, Virginia
Chippenham Hospital	Recruiting
Richmond, Virginia, United States, 23225
Principal Investigator: Michael L Arcarese, MD

Sponsors and Collaborators

Medicure

SCRI Development Innovations, LLC

Investigators

Principal Investigator:	Steven V Manoukian, MD	SCRI Development Innovations, LLC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Medicure
ClinicalTrials.gov Identifier:	NCT01522417 History of Changes
Other Study ID Numbers:	Medicure 11002
First Posted:	January 31, 2012
Last Update Posted:	March 12, 2018
Last Verified:	March 2018

Additional relevant MeSH terms:

Platelet Aggregation Inhibitors; Infarction; Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases	Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Tirofiban; Eptifibatide; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action