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

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ClinicalTrials.gov Identifier: NCT01522417
Recruitment Status : Recruiting
First Posted : January 31, 2012
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
Medicure

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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




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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522417


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

Responsible Party: Medicure
ClinicalTrials.gov Identifier: NCT01522417     History of Changes
Other Study ID Numbers: Medicure 11002
First Posted: January 31, 2012    Key Record Dates
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