Gilead, CRF commence ranolazine Phase 3 clinical trial for chronic stable angina in post-PCI setting

Gilead Sciences, Inc. (Nasdaq: GILD) and the Cardiovascular Research Foundation (CRF) today announced the initiation of RIVER-PCI (Ranolazine for Incomplete VEssel Revascularization post-PCI), a Phase 3 clinical trial evaluating the utility of ranolazine to prevent major adverse cardiovascular events (MACE) in patients with a history of chronic angina who have incomplete revascularization following percutaneous coronary intervention (PCI). RIVER-PCI will enroll 2,600 patients at approximately 200 investigative centers in the United States, Canada, Europe and Israel.

“Ranolazine has established safety and efficacy as treatment for chronic stable angina, but this is the first time the therapy is being studied specifically in a post-PCI setting as part of a randomized clinical trial”

PCI is a common procedure used to revascularize (unblock) narrowed coronary arteries and improve blood flow to the heart. Incomplete revascularization is defined as having residual disease (50 percent or greater stenosis or narrowing) following the PCI in one or more coronary arteries.

"Despite the widespread use of revascularization technologies and optimal medical therapy for coronary artery disease, the incidence of angina after PCI remains high, contributing to repeat procedures and hospitalizations, as well as increased outpatient testing and resource utilization," said Gregg W. Stone, MD, Professor of Medicine and Director of Cardiovascular Research and Education at Columbia University Medical Center (CUMC) and Co-Director of the Medical Research and Education Division at CRF. "In analyses of registries and clinical trial data, recurrent anginal or ischemic symptoms after PCI have been found to be more common in patients with incomplete revascularization, suggesting that new therapeutic strategies are needed."

"Ranolazine has established safety and efficacy as treatment for chronic stable angina, but this is the first time the therapy is being studied specifically in a post-PCI setting as part of a randomized clinical trial," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We are pleased to partner with CRF on this study, which will determine if the addition of ranolazine to standard therapy is effective in reducing post-PCI ischemic events, including reductions in post-PCI hospitalization, repeat PCI and the incidence of myocardial infarction and death."

RIVER-PCI will be led by principal study investigator Giora Weisz, MD, Director of Cardiovascular Research at CUMC and chaired by Dr. Stone.

Ranolazine is indicated for the treatment of chronic angina. Ranolazine has not been determined to be safe or efficacious as a treatment to reduce major adverse cardiovascular events in patients who have undergone PCI.