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

This study is currently recruiting participants.

Verified February 2013 by Medicure

Sponsor:

Collaborator:

Sarah Cannon Research Institute

Information provided by (Responsible Party):

Medicure

ClinicalTrials.gov Identifier:

NCT01522417

First received: January 27, 2012

Last updated: February 13, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2012

Last Updated Date

February 13, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01522417 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Infarction
Acute Coronary Syndromes
Unstable Angina

Intervention ^ICMJE

Drug: 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 after the procedure.
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.

Study Arm (s)

Experimental: 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 after the procedure.

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: 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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

September 2014

Estimated Primary Completion Date

September 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age >18 years of age
Scheduled to undergo PCI with an approved device in one or more 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sean Cahill, M Biotech

204-928-7202

scahill@medicure.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01522417

Other Study ID Numbers ^ICMJE

Medicure 11002

Has Data Monitoring Committee

Responsible Party

Medicure

Study Sponsor ^ICMJE

Medicure

Collaborators ^ICMJE

Sarah Cannon Research Institute

Investigators ^ICMJE

Principal Investigator:

Steven V Manoukian, MD

Sarah Cannon Research Institute

Information Provided By

Medicure

Verification Date

February 2013

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

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