title: Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (RIVER-PCI) trial.
abstract: BACKGROUND
  Incomplete 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.
  
  
  METHODS
  RIVER-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.
  
  
  CONCLUSIONS
  RIVER-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.
authors.affiliation: NewYork Presbyterian Hospital, Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY. Electronic address: gw2128@columbia.edu.
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
authors.forename: Ramin
authors.initials: R
authors.lastname: Farzaneh-Far
authors.forename: Ori
authors.initials: O
authors.lastname: Ben-Yehuda
authors.forename: Bernard
authors.initials: B
authors.lastname: Debruyne
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
authors.forename: Amir
authors.initials: A
authors.lastname: Lerman
authors.forename: Ehtisham
authors.initials: E
authors.lastname: Mahmud
authors.forename: Karen P
authors.initials: KP
authors.lastname: Alexander
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Ann
authors.initials: A
authors.lastname: Olmsted
authors.forename: Gennyne A
authors.initials: GA
authors.lastname: Walker
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000083:Acetanilides / Q000627:therapeutic use*; D000787:Angina Pectoris / Q000628:therapy*; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention; D010879:Piperazines / Q000627:therapeutic use*; D011788:Quality of Life; D000069458:Ranolazine; D019233:Retreatment / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D000083:Acetanilides; D004791:Enzyme Inhibitors; D010879:Piperazines; D000069458:Ranolazine