Survival of myocardial infarction long-term evaluation (SMILE) study: Rationale, design, organization, and outcome definitions

Abstract

The rationale, design, organization, and outcome definitions of the Survival of Myocardial Infarction Long-term Evaluation (SMILE) study are described in detail. Recruitment of a total of 1500 patients (750 per treatment group) has been planned for this multicenter, double-masked, randomized, placebo-controlled trial investigating the effects of oral treatment with zofenopril calcium (7.5-30 mg twice a day) on the combined short-term total mortality and occurrence of severe refractory congestive heart failure in patients with acute anterior myocardial infarction (AMI). Secondary outcomes of the study include recurrent myocardial infarction, angina, and progression of congestive heart failure, as well as long-term mortality. Patients are initially treated in hospital within 24 hr from the onset of symptoms of AMI and their active follow-up is continued for 6 weeks. In addition, the patients will be passively followed for 12 months from the index AMI to assess vital status and the occurrence of congestive heart failure. The trial data are analyzed on an intention-to-treat basis. An international independent policy and safety monitoring board is acting as the overall supervisory body and is responsible for the ethical conduct of the trial. A scientific committee is responsible for the scientific aspects of the trial and for the regular review of the progress of the study.