Document Detail


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.
MedLine Citation:
PMID:  9514453     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
G G Schwartz; M F Oliver; M D Ezekowitz; P Ganz; D Waters; J P Kane; M Texter; M L Pressler; D Black; B R Chaitman; A G Olsson
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The American journal of cardiology     Volume:  81     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  1998 Mar 
Date Detail:
Created Date:  1998-04-07     Completed Date:  1998-04-07     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  578-81     Citation Subset:  AIM; IM    
Affiliation:
San Francisco VA Medical Center, Department of Medicine and Cardiovascular Research Institute, University of California, 94121, USA.
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MeSH Terms
Descriptor/Qualifier:
Angina, Unstable / drug therapy*
Anticholesteremic Agents / therapeutic use*
Heptanoic Acids / therapeutic use*
Humans
Multicenter Studies as Topic
Myocardial Infarction / drug therapy*
Myocardial Ischemia / prevention & control*
Pyrroles / therapeutic use*
Randomized Controlled Trials as Topic
Recurrence
Research Design*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anticholesteremic Agents; 0/Heptanoic Acids; 0/Pyrroles; 110862-48-1/atorvastatin
Comments/Corrections
Comment In:
Am J Cardiol. 1998 Sep 1;82(5):703   [PMID:  9732912 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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