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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2015 by Medicure.
Recruitment status was: Recruiting

Sponsor:

Collaborator:

SCRI Development Innovations, LLC

Information provided by (Responsible Party):

Medicure

ClinicalTrials.gov Identifier:

NCT01522417

First received: January 27, 2012

Last updated: April 6, 2015

Last verified: April 2015

History of Changes

Purpose

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	Intervention	Phase
Myocardial Infarction Acute Coronary Syndromes Unstable Angina	Drug: Short Tirofiban Drug: Eptifibatide Drug: Long Tirofiban	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Tirofiban hydrochloride Eptifibatide

U.S. FDA Resources

Further study details as provided by Medicure:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	675
Study Start Date:	April 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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) 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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522417

Contacts


Contact: Michael Janzen, PhD	204-928-7908	mjanzen@medicure.com

Locations


United States, Florida
Osceola Regional Medical Center	Completed
Kissimmee, Florida, United States, 34741
Northside Hospital	Completed
St. Petersburg, Florida, United States, 33709
United States, Georgia
Emory University Hospital Midtown	Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Wassim Jaber, MD
Emory University Hospital	Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Habib Samady, MD
North Georgia Heart Center	Recruiting
Gainesville, Georgia, United States, 30501
Principal Investigator: J J Marshall, MD
Redmond Regional Medical Center	Recruiting
Rome, Georgia, United States, 30165
Principal Investigator: Hector R Picon, MD
Archbold Medical Center	Recruiting
Thomasville, Georgia, United States, 31792
Principal Investigator: Clay Sizemore, MD
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	Recruiting
Doylestown, Pennsylvania, United States, 18901
Principal Investigator: Joseph F McGarvey, MD
Penn Presbyterian Medical Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: William H Matthai, MD
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


Responsible Party:	Medicure
ClinicalTrials.gov Identifier:	NCT01522417 History of Changes
Other Study ID Numbers:	Medicure 11002
Study First Received:	January 27, 2012
Last Updated:	April 6, 2015

Additional relevant MeSH terms:


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 Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 18, 2017

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