title: 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.
abstract: The goal of the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) study is to determine whether early, rapid, and profound cholesterol lowering therapy with atorvastatin can reduce early recurrent ischemic events in patients with unstable angina or non-Q-wave acute myocardial infarction. Within 1 to 4 days of hospitalization for one of these conditions, 2,100 patients will be randomly assigned to receive atorvastatin, 80 mg/day, or placebo in a double-blind design. Both groups receive dietary counseling. Over a 16-week follow-up period, the primary outcome measure is the time to occurrence of an ischemic event, defined as death, nonfatal acute myocardial infarction, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia requiring emergency rehospitalization. Secondary outcome measures are the time to occurrence and incidence of each of the primary outcome components, as well as nonfatal stroke, worsening angina, congestive heart failure requiring hospitalization, and need for coronary revascularization not anticipated before randomization. The sample size 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 utility of profound cholesterol lowering as an early intervention in acute coronary syndromes.
authors.affiliation: San Francisco VA Medical Center, Department of Medicine and Cardiovascular Research Institute, University of California, 94121, USA.
authors.forename: G G
authors.initials: GG
authors.lastname: Schwartz
authors.forename: M F
authors.initials: MF
authors.lastname: Oliver
authors.forename: M D
authors.initials: MD
authors.lastname: Ezekowitz
authors.forename: P
authors.initials: P
authors.lastname: Ganz
authors.forename: D
authors.initials: D
authors.lastname: Waters
authors.forename: J P
authors.initials: JP
authors.lastname: Kane
authors.forename: M
authors.initials: M
authors.lastname: Texter
authors.forename: M L
authors.initials: ML
authors.lastname: Pressler
authors.forename: D
authors.initials: D
authors.lastname: Black
authors.forename: B R
authors.initials: BR
authors.lastname: Chaitman
authors.forename: A G
authors.initials: AG
authors.lastname: Olsson
mesh_terms: D000789:Angina, Unstable / Q000188:drug therapy*; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D000069059:Atorvastatin; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000188:drug therapy*; D017202:Myocardial Ischemia / Q000517:prevention & control*; D011758:Pyrroles / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D011758:Pyrroles; D000069059:Atorvastatin