Effects of rosuvastatin and atorvastatin on the apolipoprotein B/apolipoprotein A-1 ratio in patients with an acute coronary syndrome: The CENTAURUS trial design.
BACKGROUND
The mechanism underlying rapid, statin-induced event reduction in patients with an acute coronary syndrome (ACS) remains to be clarified.


OBJECTIVE
The primary objective is to compare the efficacy of rosuvastatin 20 mg/day and atorvastatin 80 mg/day in reducing the apolipoprotein B/apolipoprotein A-1 (apoB/apoA-1) ratio at three months, in ACS patients. Secondary objectives include a comparison of the effects of early-started rosuvastatin and placebo on inflammatory markers.


METHODS
This is a randomized, double-blind, parallel-group study. Patients with non-ST-segment elevation ACS, symptom onset less than 48 h before admission, and for whom a percutaneous coronary intervention is planned, are eligible for inclusion and are randomized into three groups (G1, G2 and G3). The study comprises two double-blind periods. Period 1 starts at hospital admission and lasts until Day 0 (discharge or less or equal to 6 days after admission); patients in G1 receive one tablet of rosuvastatin 20 mg/day and patients in G2 and G3 receive one matching placebo tablet per day. Period 2 starts at Day 0 and lasts for three months; patients in G1 continue to receive rosuvastatin 20 mg/day, patients in G2 receive rosuvastatin 20 mg/day and patients in G3 receive atorvastatin 80 mg/day. Recruitment of 1075 patients will ensure an 80 power to detect a 3% difference in percentage change in the apoB/apoA-1 ratio and a 20% difference in percentage change in high-sensitivity C-reactive protein.


RESULTS
Inclusion phase is complete; results will be reported at a later date.


CONCLUSIONS
This is the first trial investigating the effect of statins on apolipoproteins in ACS patients.
Lablanche
Jean-Marc
JM
Hôpital cardiologique, CHRU de Lille, Lille, France.
Danchin
Nicolas
N
Farnier
Michel
M
Tedgui
Alain
A
Vicaut
Eric
E
Alonso
Joaquim
J
Crean
Peter
P
Leone
Attilio
A
Morais
Joa
J
Santini
Massimo
M
Licour
Muriel
M
Farah
Mohamed
M
Tardif
Jean-Claude
JC
D054058:Acute Coronary Syndrome / Q000097:blood / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D016632:Apolipoprotein A-I / Q000097:blood* / Q000187:drug effects; D001055:Apolipoproteins B / Q000097:blood* / Q000187:drug effects; D000069059:Atorvastatin; D004311:Double-Blind Method; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D006538:Heptanoic Acids / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D011743:Pyrimidines / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D011758:Pyrroles / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*
D016632:Apolipoprotein A-I; D001055:Apolipoproteins B; D005464:Fluorobenzenes; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D000069059:Atorvastatin