MIRACL
Trial question
What is the role of atorvastatin in patients (aged ≥ 18 years) with unstable angina or non-Q-wave acute MI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 3086
3086 patients (1074 female, 2012 male).
Inclusion criteria: patients (aged ≥ 18 years) with unstable angina or non-Q-wave acute MI.
Key exclusion criteria: Q-wave acute MI within the preceding 4 weeks, left bundle-branch block or paced ventricular rhythm, severe congestive HF, severe anemia, renal failure requiring dialysis, or hepatic dysfunction.
Interventions
N=1538 atorvastatin (80 mg/day between 24 to 96 hours after hospitalization).
N=1548 placebo (matching placebo between 24 and 96 hours after hospitalization).
Primary outcome
Death, nonfatal MI, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia requiring emergency hospitalization
14.8%
17.4%
17.4 %
13.0 %
8.7 %
4.3 %
0.0 %
Atorvastatin
Placebo
Borderline significant
decrease ▼
Borderline significant decrease in death, nonfatal MI, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia requiring emergency hospitalization (14.8% vs. 17.4%; RR 0.84, 95% CI 0.7 to 1).
Secondary outcomes
Significant decrease in symptomatic ischemia with objective evidence and requiring emergency rehospitalization (6.2% vs. 8.4%; RR 0.74, 95% CI 0.57 to 0.95).
Significant increase in abnormal liver transaminases (2.5% vs. 0.6%; RR 4.17, 95% CI 1.7 to 6.64).
Safety outcomes
Significant differences in abnormal liver transaminases (2.5% vs. 0.6%, p < 0.001).
Conclusion
In patients (aged ≥ 18 years) with unstable angina or non-Q-wave acute MI, atorvastatin was superior to placebo with respect to death, nonfatal myocardial infarction, cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia requiring emergency hospitalization.
Reference
Schwartz GG, Olsson AG, Ezekowitz MD et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001 Apr 4;285(13):1711-8.
Open reference URL