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
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Tracking Information | |||||
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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 |
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 |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
550 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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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 |
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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 |