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

Tracking Information
First Submitted Date ICMJE	January 27, 2012
First Posted Date ICMJE	January 31, 2012
Last Update Posted Date	March 12, 2018
Study Start Date ICMJE	April 2012
Estimated Primary Completion Date	March 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 30, 2012)	The composite incidence of death, PCI-related myocardial infarction, urgent target vessel revascularization or major bleeding [ Time Frame: 48 hours ]
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; (submitted: January 30, 2012)	The composite incidence of death, PCI-related myocardial infarction or urgent target vessel revascularization [ Time Frame: 48 hours ]
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; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina
Intervention ICMJE	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
Study Arms	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) (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). Intervention: Drug: Long Tirofiban
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; (submitted: February 27, 2018)	550
Original Estimated Enrollment ICMJE; (submitted: January 30, 2012)	600
Estimated Study Completion Date	July 2019
Estimated Primary Completion Date	March 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Debbie Douglas, PhD 204-594-3624 ddouglas@medicure.com
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01522417
Other Study ID Numbers ICMJE	Medicure 11002
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medicure
Study Sponsor ICMJE	Medicure
Collaborators ICMJE	SCRI Development Innovations, LLC
Investigators ICMJE	Principal Investigator: Steven V Manoukian, MD SCRI Development Innovations, LLC
PRS Account	Medicure
Verification Date	March 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP