Study Design

Study Design:

Patients Screened: 912
Patients Enrolled: 153
Mean Follow Up: One month
Mean Patient Age: Mean age 64 years
Female: 30
Mean Ejection Fraction: Mean ejection fraction at baseline 54% in each arm

Patient Populations:

Presence of typical stable effort angina, positive stress test, and indication for coronary angioplasty

Exclusions:

Acute MI within three months; unstable angina; any increase in CK-MB, troponin I, or myoglobin above ULN at the time of randomization; any increase in liver enzymes (AST/ALT); left ventricular ejection fraction <30%; renal failure with creatinine >3 mg/dl; history of liver or muscle disease; and current or previous treatment with statins

Primary Endpoints:

Occurrence of MI, defined as a post-procedural increase of CK-MB >2 times above ULN

Secondary Endpoints:

Any post-procedural increase of markers of myocardial injury (CK-MB, troponin I, and myoglobin) ULN; mean peak values of CK-MB, troponin I, and myoglobin after intervention; and occurrence of major adverse cardiac events (death, MI, or need for unplanned revascularization) at one-month follow-up

Drug/Procedures Used:

Patients scheduled for elective PCI were randomized to atorvastatin (40 mg/day, n=76) or placebo (n=77) seven days prior to the procedure. Serial blood draws were taken at baseline and at eight and 24 hours after the procedure to measure creatine kinase-MB (CK-MB), troponin I, and myoglobin levels. Postprocedure, patients in both arms were treated with atorvastatin (40 mg/day).

Concomitant Medications:

Aspirin (100 mg/day); ticlopidine 250 mg twice per day for at least three days before the procedure or clopidogrel 300 mg at least six hours before the procedure. Ticlopidine (250 mg twice per day) or clopidogrel (75 mg/day) was continued for one month, unless treated with drug-eluting stents, in which case treatment was continued for six months.