Randomised, Double-Blind, Placebo-Controlled Trial of Ivabradine in Patients with Acute Coronary Syndrome: Effects of the I f Current Inhibitor Ivabradine on Reduction of Inflammation Markers in Patients with Acute Coronary Syndrome—RIVIERA Trial Study Design and Rationale

Abstract

Elevated levels of serum inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP) represent independent risk factors for further cardiovascular events. In an atherosclerosis model, selective heart rate (HR) reduction with ivabradine has been shown to decrease markers of vascular oxidative stress, to improve endothelial function, and to reduce atherosclerotic plaque formation. We hypothesized that the addition of ivabradine to standard medical therapy has a beneficial effect on markers of inflammatory stress in acute coronary syndromes (ACS) patients. RIVIERA is a unicenter, randomized, double-blind, placebo-controlled trial involving 1,270 patients of either gender admitted to hospital with non ST elevation ACS. The primary study aim is to evaluate the effects of ivabradine therapy, initiated at the time of hospital admission, on hs-CRP levels. There is also a combined secondary endpoint i.e. to assess the effects of ivabradine on the occurrence of death, nonfatal myocardial infarction, recurrent symptomatic ischemia, urgent revascularization, and cardiac arrest at 30-days and 1-year follow up. We hypothesize that ivabradine therapy, when started immediately after hospital admission for ACS, will result in the reduction of hs-CRP levels and the improvement of cardiovascular outcome.