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news.Gilead Sciences and the Cardiovascular Research Foundation (CRF) have commenced RIVER-PCI (Ranolazine for Incomplete VEssel Revascularization post-PCI), Phase 3 clinical trial to assess ranolazine in preventing major adverse cardiovascular events (MACE).
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The trial will involve 2,600 patients with a history of chronic angina who have incomplete revascularization following percutaneous coronary intervention (PCI).
Ranolazine is an extended-release tablet approved under the tradename Ranexa, used to treat chronic angina, which can inhibit the cardiac late sodium current.
PCI is a procedure used to revascularize narrowed coronary arteries and improve blood flow to the heart.
During the course of the trial, post-PCI patients will be randomized in a 1:1 ratio to receive twice-daily ranolazine or matching placebo in addition to their standard medical therapy.
The primary efficacy endpoint is the incidence of MACE, as defined by the composite of cardiovascular death, myocardial infarction (MI) or hospitalization for ischemia or angina.
Secondary endpoints include the incidence of the individual components of the primary endpoint, sudden cardiac death and evaluation of quality of life and health-related costs.