• Giora Weisz, Ramin Farzaneh-Far, Ori Ben-Yehuda, Bernard Debruyne, Gilles Montalescot, Amir Lerman, Ehtisham Mahmud, Karen P Alexander, E Magnus Ohman, Harvey D White, Ann Olmsted, Gennyne A Walker, and Gregg W Stone.
• NewYork Presbyterian Hospital, Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY. Electronic address: gw2128@columbia.edu.
• Am. Heart J. 2013 Dec 1;166(6):953-959.e3.

BackgroundIncomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is common and is associated with increased rates of rehospitalization, revascularization, and mortality. Adjunctive pharmacotherapy with ranolazine, an inhibitor of the late sodium current with anti-ischemic properties, may be effective in reducing recurrent events after PCI in patients with ICR.Trial DesignRIVER-PCI is a phase 3, randomized, double-blind, placebo-controlled, international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI. Approximately 2,600 participants with ICR post-PCI will be randomized in a 1:1 ratio to ranolazine or matched placebo within 14 days of an index PCI. The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization. Participants will be followed up for a minimum of 1 year and until at least 720 confirmed primary end point events have occurred. Secondary end points include sudden cardiac death, cardiovascular death, myocardial infarction, and measures of quality of life and cost-effectiveness. The evaluation of long-term safety will include all-cause mortality, stroke, transient ischemic attack, and hospitalization for heart failure. Enrollment commenced in November 2011 and was completed in summer 2013.ConclusionsRIVER-PCI is a novel, large-scale, international, randomized, double-blind, placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI.© 2013.

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