Can intensive lipid-lowering therapy with statins ameliorate atherosclerosis in japanese patients? - Rationale and design of the JART study

Aim: in japan,heart disease and cerebral ischemic disease are major causes of death. a decrease in the level of low-density lipoprotein cholesterol (ldl-c) through intensive treatment with statins positively correlates with a reduction in the volume of plaques in patients with cardiovascular disease. the meteor trial,evaluating the effect of rosuvastatin on carotid intima-media thickness (imt),was conducted only in europe and the us. here we planned another trial,the justification for atherosclerosis regression treatment (jart) study,to clarify the efficacy of intensive lipid-lowering therapy with rosuvastatin in japanese with atherosclerosis. methods and results: four hundred patients with hypercholesterolemia (ldl-c ≥140 mg/dl) and a maximum imt of ≥1.1 mm will be treated for 24 months either with intensive lipid-lowering therapy with rosuvastatin (target ldl-c levels: 80 mg/dl for primary prevention,and 70 mg/dl for secondary prevention) or conventional lipid-lowering therapy with pravastatin (target ldl-c level: complying with jasgl2007). the primary endpoint will be the percent change of mean-imt and the objectives of the study are to compare the two protocols. conclusion: the jart trial is a prospective,randomized,open-label,blinded end-point evaluation,multi-center,parallel-group,comparative study to examine the regressive effect of intensive lipid-lowering therapy with statins on atherosclerosis by evaluating imt in the japanese population.