Medicure Announces the Completion of Shortened AGGRASTAT Versus Integrilin in Percutaneous Coronary Intervention (SAVI-PCI) Study
WINNIPEG, Dec. 17, 2019 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the completion of the Shortened AGGRASTAT® (tirofiban hydrochloride) injection versus Integrilin® (eptifibatide) in Percutaneous Coronary Intervention (SAVI-PCI) Clinical Trial.
SAVI-PCI was a randomized, multicenter, open-label study enrolling 535 patients at 13 sites in the United States, which compared tirofiban high-dose bolus injection followed by a maintenance infusion for 1-2 hours post-PCI to label-dosing eptifibatide (double bolus followed by 12-18 hour maintenance infusion). Comparisons to a long-infusion tirofiban arm (high-dose bolus injection followed by 12-18 hour maintenance infusion post-PCI) were also performed. The primary endpoint of the study was to assess whether the short infusion tirofiban regimen in patients undergoing PCI was non-inferior to the aforementioned eptifibatide regimen. The primary endpoint was a composite rate of death, periprocedural myonecrosis, urgent target vessel revascularization (uTVR) or in-hospital, non-CABG related major bleeding within 48 hours following PCI or hospital discharge, whichever comes first, quantified according to REPLACE-2 criteria. This study was sponsored by Medicure.
Topline results of the SAVI-PCI trial will be communicated in a subsequent press release in Q1 of 2020.
"We are very pleased with the completion of enrollment of SAVI-PCI. The study reflects our investment in the Aggrastat brand, and our partnership with leading cardiologists across the United States, providing clinical data involving Aggrastat that reflects contemporary practice", said Albert Friesen, PhD, CEO of Medicure.
AGGRASTAT® (tirofiban hydrochloride) injection is a non-peptide antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor and inhibits the final common pathway in platelet aggregation. AGGRASTAT® is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).1
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AGGRASTAT® (tirofiban hydrochloride) is a registered trademark of Medicure International Inc.
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SOURCE Medicure Inc.
Company Codes: OTC-PINK:MCUJF, TorontoVE:MPH