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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 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: April 6, 2015
Last verified: April 2015
History of Changes

January 27, 2012
April 6, 2015
April 2012
March 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01522417 on ClinicalTrials.gov Archive Site
The composite incidence of death, PCI-related myocardial infarction or urgent target vessel revascularization [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myocardial Infarction
  • Acute Coronary Syndromes
  • Unstable Angina
  • 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
  • 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
  • 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
  • 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).

    Intervention: Drug: Short Tirofiban
  • 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).

    Intervention: Drug: Eptifibatide
  • 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).

    Intervention: Drug: Long Tirofiban
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
675
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Michael Janzen, PhD 204-928-7908 mjanzen@medicure.com
United States
 
NCT01522417
Medicure 11002
No
Not Provided
Not Provided
Medicure
Medicure
SCRI Development Innovations, LLC
Principal Investigator: Steven V Manoukian, MD SCRI Development Innovations, LLC
Medicure
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP