April 19, 2011 - Investigator-initiated European multicenter trial of 1,000 acute heart attack patients will examine the ability of cyclosporine to protect cardiac tissue — NeuroVive Pharmaceutical and Hospices Civils de Lyon (HCL) announced the enrollment and treatment of the first patient in the European multicenter trial of myocardial infarction (the CIRCUS study). NeuroVive’s advanced CicloMulsion™ cremophor-free IV cyclosporine formulation is used in this study of 1,000 patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction to examine cyclosporine’s ability to protect cardiac tissue. The double-blind, placebo-controlled, investigator-initiated study is being led by trial sponsor Professor Michel Ovize, MD, PhD, of HCL. NeuroVive is supporting the study by providing active drug, placebo and drug logistics. The study will enroll patients at 40 centers in France and additional European sites.
Professor Michel Ovize comments:
"Patients with myocardial infarction often undergo emergency percutaneous coronary intervention in which a catheter passed through the major blood vessels restores blood flow to blocked coronary arteries. Even after blood flow is restored, damage to the heart muscle continues to progress through what is known as reperfusion injury. Small-size proof-of-concept studies have shown that reperfusion injury may account for as much as 30-40% of total infarction-related myocardial damage and that timely therapeutic interventions can prevent this damage (Staat et al. Circulation 2005; Thibault et al. Circulation 2008). From a clinical point of view, it is critical to develop a drug to protect cardiac tissue during PCI and hopefully improve clinical outcome.”... NeuroVive Pharmaceutical's Press Release -