The CardioVascular Insitute of Northwest Florida has been chosen to participate in the international RIVER-PCI clinical trial. The RIVER-PCI trial is a Phase 3, randomized study of the effects of Ranolzine (Ranexa®) on major adverse cardiovascular events in patients with a history of chronic angina who undergo coronary intervention with evidence of incomplete revascularization. The CardioVascular Institute of Northwest Florida is one of only two sites selected from the Panhandle and has been enrolling eligible patients since April 2012.
Despite the widespread use of coronary stents and medical therapy for coronary artery disease, the incidence of chest pain (angina) after coronary intervention remains high, thus leading to repeat procedures and hospitalizations. The primary objective of the RIVER-PCI clinical trial is to determine the effectiveness of Ranolazine when used as part of standard medical therapy in patients with chronic angina who have evidence of “incomplete revascularization”, or blockages not yet severe enough to undergo coronary stenting or surgical bypass. The RIVER-PCI clinical trial will randomize approximately 2600 patients across the United States, Canada, Europe and Israel. Currently, stents are only approved to treat blockages greater than 70%. However, patients with blockages less than 70% are still at risk for recurrent chest pain or heart attacks. The goal of the study is to determine whether Ranolazine will decrease this risk and decrease the need for repeat procedures and hospitalizations. Patients randomized to Ranolazine will be provided the medication, and all patients that elect to participate in this study will be provided clinical follow-up.
The cardiologists at the CardioVascular Insitute of Northwest Florida have demonstrated a strong commitment to clinical research and strive to provide the most progressive, cutting-edge therapy and widest selections of options for their patients. They have quickly become one of the major enrollment institutions in the world for the RIVER-PCI study.
Clinical Research at the CardioVascular Institute of Northwest Florida is coordinated by Linda Deneen, RN, BSN, who serves as the Clinical Research Coordinator. Ms. Deneen has managed several clinical trials during her seven-year career as a Clinical Research Coordinator. She also plays an integral role in our local Institutional Review Board (IRB) which overseas all clinical trials performed within Bay County. Linda previously served as the Research Coordinator at Bay Medical Center/Sacred Heart Health Systems. She has proven to be a tremendous asset and supervises all the clinical research trials currently underway at the CardioVascular Institute of Northwest Florida.