Effects of rosuvastatin and atorvastatin on the apolipoprotein B/apolipoprotein A-1 ratio in patients with an acute coronary syndrome: The CENTAURUS trial design.

Author(s): Lablanche JM, Danchin N, Farnier M, Tedgui A, Vicaut E, Alonso J, Crean P, Leone A, Morais J, Santini M, Licour M, Farah M, Tardif JC

Affiliation(s): Hopital cardiologique, CHRU de Lille, Lille, France.

Publication date & source: 2008-06, Arch Cardiovasc Dis., 101(6):399-406. Epub 2008 Aug 20.

Publication type:

BACKGROUND: The mechanism underlying rapid, statin-induced event reduction in patients with an acute coronary syndrome (ACS) remains to be clarified. AIM: The primary objective is to compare the efficacy of rosuvastatin 20mg/day and atorvastatin 80mg/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 48h 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 20mg/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 20mg/day, patients in G2 receive rosuvastatin 20mg/day and patients in G3 receive atorvastatin 80mg/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. CONCLUSION: This is the first trial investigating the effect of statins on apolipoproteins in ACS patients.