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Medicure Announces that the Shortened AGGRASTAT® Versus INTEGRILIN® in Percutaneous Coronary Intervention (SAVI-PCI) Study has Met its Primary Endpoint
Medicure Announces that the Shortened AGGRASTAT® Versus INTEGRILIN® in Percutan...
About this update from Medicure Inc.
[{"type":"text","content":"\n \n \n \n Medicure Announces that the Shortened AGGRASTAT® Versus INTEGRILIN® in Percutaneous Coronary Intervention (SAVI-PCI) Study has Met its Primary Endpoint\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n \n \n \n \n \n Canada NewsWire\n \n \n \n \n \n WINNIPEG, MB\n \n ,\n \n Nov. 4, 2021\n \n /CNW/ - Medicure Inc. (\"Medicure\" or the \"Company\") (TSXV: MPH) (OTC: MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the results from the SAVI-PCI clinical trial demonstrating that the use of short infusion AGGRASTAT\n \n ®\n \n (tirofiban hydrochloride) injection was non-inferior to label-dosing INTEGRILIN\n \n ®\n \n (eptifibatide) or long-infusion AGGRASTAT\n \n ®\n \n in a primary endpoint of combined efficacy and major bleeding.\n \n \n SAVI-PCI was a randomized, multicenter, open-label study enrolling 535 patients at 13 sites in the\n \n United States\n \n comparing a bolus plus short (1 – 2 hour) infusion AGGRASTAT\n \n ®\n \n to label-dosing (double-bolus plus 12 – 18 hour infusion) INTEGRILIN\n \n ®\n \n . A third arm of bolus plus long (12 – 18 hour) infusion AGGRASTAT\n \n ®\n \n was later added to the study. The primary endpoint was the non-inferiority (margin 19.1%) of a composite of death, periprocedural myonecrosis (PPM), urgent target vessel revascularization (uTVR) or in-hospital, non-CABG related REPLACE-2 defined major bleeding within 48 hours following PCI or hospital discharge, whichever came first (\n \n NCT01522417\n \n ). This study was sponsored by Medicure.\n \n \n The study showed that short infusion AGGRASTAT\n \n ®\n \n was non-inferior to both label-dosing INTEGRILIN\n \n ®\n \n (34.2% vs 30.9%, Risk Difference = 0.0323, 95% CI [-0.0599 – 0.1245]) and long-infusion AGGRASTAT\n \n ®\n \n (34.2% vs 39.0%, Risk Difference = -0.0487, 95% CI [-0.1569 – 0.0595]) with respect to the primary endpoint. The primary endpoint was driven by the occurrence of PPM, defined as a troponin value ≥ 3 times the upper limit of normal when ...