WINNIPEG, MANITOBA--(Marketwire - Jan. 30, 2012) - Medicure Inc. ("Medicure" or the "Company") (TSX VENTURE:MPH)(PINKSHEETS:MCUJ) is pleased to announce its plans for a new clinical trial of AGGRASTAT® (tirofiban HCl) entitled "Shortened Aggrastat Versus Integrilin in Percutaneous Coronary Intervention" (SAVI-PCI).
SAVI-PCI (pronounced savvy) will be a randomized, open-label study enrolling approximately 600 patients undergoing percutaneous coronary intervention (PCI) at sites across the United States. The study is designed to evaluate whether patients receiving the investigational, High-Dose Bolus (HDB) regimen of AGGRASTAT (25 mcg/kg bolus over 3 minutes) followed by an infusion of 0.15 mcg/kg/min for a shortened duration of 2 hours will have outcomes that are similar, or "non-inferior," to patients receiving an 18 hour infusion of Integrilin® (eptifibatide) (Merck & Co., Inc.) at its FDA approved dosing regimen. The primary objective of SAVI-PCI is to demonstrate AGGRASTAT is non-inferior to Integrilin with respect to the composite endpoint of death, PCI-related myocardial infarction, urgent target vessel revascularization, or major bleeding within 48 hours following PCI or hospital discharge. The secondary objectives of this study include the assessment of safety as measured by the incidence of major bleeding. The first patient is anticipated to be enrolled in spring 2012. The Principal Investigator for the study is Steven V. Manoukian, MD, Director of Cardiovascular Research at the Sarah Cannon Research Institute (SCRI).
"SAVI-PCI has the potential to advance a promising new treatment strategy for PCI by validating that a short regimen of tirofiban provides similar efficacy compared to the standard regimen of eptifibatide. Furthermore, it is hoped this regimen will be associated with lower bleeding risk, more efficient throughput and lower cost. This is also a major milestone in SCRI's cardiovascular research initiative and we are excited to be a part of it," commented Dr. Manoukian.
Both AGGRASTAT and Integrilin are reversible, small molecule Glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors that have been shown in clinical trials to reduce the combined incidence of death and myocardial infarction in patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI) undergoing cardiac catheterization when compared to heparin. These agents work by preventing the ability of platelets to aggregate together. These platelet aggregates - commonly known as blood clots - can result in a partial or complete blockage of the coronary artery if left untreated.
Bleeding is a common adverse reaction associated with the use of GP IIb/IIIa inhibitors due to their unique ability to prevent and disaggregate blood clots. A patient's risk of bleeding is an important factor when determining an optimal treatment approach and, in some cases, complicates or limits the use of these agents. With the SAVI-PCI study, the investigators will explore whether AGGRASTAT HDB plus a shortened infusion can reduce the risk of bleeding while maintaining comparable ischemic protection relative to the currently practiced 18 hour infusion of Integrilin. Other studies have indicated that shortening the infusion duration of GP IIb/IIIa inhibitors can potentially lead to a reduction in bleeding complications for patients undergoing PCI.