A randomized controlled trial of the efficacy and safety of varenicline for smoking cessation after acute coronary syndrome: Design and methods of the Evaluation of Varenicline in Smoking Cessation for Patients Post-Acute Coronary Syndrome trial

Background Patients who continue to smoke after an acute coronary syndrome (ACS) have a significantly increased risk of reinfarction and death compared with those who quit. Varenicline is a first-line smoking cessation therapy with proven efficacy in the general population. However, its efficacy and safety immediately after an ACS are unknown. Methods The EVITA trial is a multicenter, double-blind, randomized, placebo-controlled trial (NCT00794573). The primary objective is to evaluate the efficacy of varenicline after ACS in achieving biochemically validated smoking abstinence at 24 weeks. The secondary objectives are to examine the efficacy of varenicline for smoking abstinence and reduction in daily cigarette consumption at 52 weeks and to describe the occurrence of adverse events. Three hundred and two patients motivated to quit smoking were enrolled in the United States and Canada from November 2009 to December 2014 while hospitalized with an ACS. These participants were randomized (1:1) to either varenicline (1.0 mg twice daily) or placebo for 12 weeks. The trial includes follow-ups by telephone at weeks 1, 2, and 8 and clinic visits at weeks 4, 12, 24, and 52. Data collected include demographic and clinical characteristics, self-reported smoking, exhaled carbon monoxide (an indicator of current smoking), and adverse events. Conclusion The EVITA trial will provide novel information concerning the efficacy and safety of varenicline immediately after ACS. If varenicline is efficacious in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients post-ACS.