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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Medicure
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
Medicure
ClinicalTrials.gov Identifier:
NCT01522417
First received: January 27, 2012
Last updated: November 5, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The composite incidence of death, PCI-related myocardial infarction or urgent target vessel revascularization [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 675
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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
Genders Eligible for Study:   Both
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 Recruiting
St. Petersburg, Florida, United States, 33709
Principal Investigator: Andrew Rosenthal, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Habib Samady, MD         
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Wassim Jaber, MD         
Northeast 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 Recruiting
New York, New York, United States, 10075
Principal Investigator: Varinder Singh, MD         
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

No publications provided

Responsible Party: Medicure
ClinicalTrials.gov Identifier: NCT01522417     History of Changes
Other Study ID Numbers: Medicure 11002
Study First Received: January 27, 2012
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Tirofiban
Eptifibatide
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014