RATIONALE AND DESIGN OF THE MYOCARDIAL-ISCHEMIA REDUCTION WITH AGGRESSIVE CHOLESTEROL-LOWERING (MIRACL) STUDY THAT EVALUATES ATORVASTATIN IN UNSTABLE ANGINA-PECTORIS AND IN NON-Q-WAVE ACUTE MYOCARDIAL-INFARCTION

The goal of the Myocardial Ischemia Reduction with Aggressive Choleste rol Lowering (MIRACL) study is to determine whether early, rapid, and profound cholesterol lowering therapy with atorvastatin can reduce ear ly recurrent ischemic events in patients with unstable angina or non-Q -wave acute myocardial infarction, Within 1 to 4 days of hospitalizati on for one of these conditions, 2,100 patients will be randomly assign ed to receive atorvastatin, 80 mg/day, or placebo in a double-blind de sign. Both groups receive dietary counseling. Over a 16-week follow-up period, the primary outcome measure is the time to occurrence of an i schemic event defined as death, nonfatal acute myocardial infarction, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia requiring emergency rehospitalization. Secondary outcome mea sures are the time to occurrence and incidence of each of the primary outcome components, as well as nonfatal stroke, worsening angina, cong estive heart failure requiring hospitalization, and need for coronary revascularization not anticipated before randomization. The sample siz e of 1,050 patients in each group is expected to provide 95% power to detect a 30% reduction in the primary outcome measure with a 5% level of significance. The results of the MIRACL study will determine the ut ility of profound cholesterol lowering as an early intervention in acu te coronary syndromes. (C) 1998 by Excerpta Medica, Inc.