WINNIPEG, May 10, 2012 /CNW/ - Medicure Inc. ("Medicure" or the "Company") (TSX VENTURE:MPH)(PINKSHEETS:MCUJ) is pleased to announce the commencement of enrollment in SAVI-PCI ("Shortened Aggrastat Versus Integrilin in Percutaneous Coronary Intervention") a prospective, multicenter, randomized clinical trial of its commercial product, AGGRASTAT® (tirofiban HCl), in the United States. Initiation of the study marks a significant milestone in the Company's evaluation of the High-Dose Bolus (HDB) plus short infusion regimen of AGGRASTAT.
The first sites initiated in the SAVI-PCI (pronounced savvy) study are the Centennial Heart and Vascular Center, Nashville, TN and the Levinson Heart Hospital on the Chippenham Campus of CJW Medical Center, Richmond, VA. Both facilities are part of the cardiovascular clinical site network of the Sarah Cannon Research Institute (SCRI), Nashville, TN.
"We are pleased to see the commencement of enrollment at two of our leading facilities and we look forward to seeing all sites enrolling in the near future, " commented Steven V. Manoukian, MD, Principal Investigator for the study and Director of Cardiovascular Research at the Sarah Cannon Research Institute (SCRI). "The investigational tirofiban dosing regimen being evaluated in this study has potential to provide the efficacy for which this class of therapy is known but with lower bleeding risk, more efficient throughput and lower cost."
The SAVI-PCI study will enroll 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, HDB regimen of AGGRASTAT (25 mcg/kg bolus over 3 minutes) followed by a shortened, 1 to 2 hour infusion of 0.15 mcg/kg/min will have outcomes that are similar, or "non-inferior," to patients receiving a 12 to 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.
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 aggregation of platelets and formation of blood clots which 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 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 12 to 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. It is important to note that bleeding complications have been linked to increased rates of other major complications and mortality, as well as increased overall cost of care. A goal of the SAVI-PCI study is to further optimize the safety, efficacy and efficiency of treatment used in the setting of PCI.
The study is sponsored by Medicure's subsidiary, Medicure International, Inc. in partnership with SCRI and GVI Clinical Development Solutions (CDS). SCRI is one of the largest, community-based research programs in the United States, conducting cardiology and oncology clinical trials through its affiliation with a network of hundreds of physicians. CDS is a full-service Contract Research Organization with extensive clinical development experience across a multitude of therapeutic areas, and a track record of delivering quality data on time at competitive costs.
AGGRASTAT (tirofiban HCl), in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT has been studied in a setting that included aspirin and heparin.
Bleeding is the most common complication encountered during therapy with AGGRASTAT. Administration of AGGRASTAT is associated with an increase in bleeding events classified as both major and minor bleeding events by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. AGGRASTAT should be used with caution in patients with platelet count less than 150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic hemodialysis patients. Because AGGRASTAT inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT and heparin should be discontinued.
AGGRASTAT is a parenteral non-peptide; reversible GP IIb/IIIa receptor antagonist that is marketed in the United States by Medicure Pharma, Inc. Medicure does not promote unapproved use of AGGRASTAT. Please see the AGGRASTAT Prescribing Information for approved indications, dosage regimens and safety related information. The AGGRASTAT dosing regimen and the treatment setting studied in the SAVI-PCI study have not been approved by the FDA.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of novel small molecule therapeutics. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for acute coronary syndromes in the United States, where it is sold through the Company's US subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
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