[The SMILE study: the rationale, design, organization and definition of the objectives. Survival of Myocardial Infarction Long-term Evaluation].

The rationale, design, organization and outcome definitions of the Survival of Myocardial Infarction Long-term Evaluation (SMILE) study are described in detail. The recruitment of a total of 1500 patients (750 per treatment group) has been planned for this multicenter, double-blind, randomized, placebo-controlled study to investigate 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 end-points of the study include recurrent myocardial infarction, angina, progression of congestive heart failure as well as long-term mortality. Patients are initially treated in hospital within 24 hours from the onset of symptoms of AMI and their active follow-up continued for 6 weeks. In addition, the patients will be passively followed for a total of 12 months from the index AMI to assess their vital status and the occurrence of congestive heart failure. The study data will be 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 conduction 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. We assume that the rationale and design of the SMILE trial will provide reliable information on the ability of ACE-inhibitors to reduce the occurrence of major cardiovascular events in patients with acute myocardial infarction.