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


RESULTS
Four hundred patients with hypercholesterolemia (LDL-C >or=140 mg/dL) and a maximum IMT of >or=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.


CONCLUSIONS
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.
Kurabayashi
Masahiko
M
Department of Medicine and Biological Science, Gunma University Graduate School of Medicine, Maebashi, Japan. mkuraba@med.gunma-u.ac.jp
Sakuma
Ichiro
I
Kawamori
Ryuzo
R
Daida
Hiroyuki
H
Yamazaki
Tsutomu
T
Yoshida
Masayuki
M
Hata
Mitsumasa
M
Masuda
Izuru
I
Kaku
Kohei
K
Yokoi
Hiroyoshi
H
Kishimoto
Junji
J
Nohara
Ryuji
R
D000328:Adult; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D017035:Pravastatin / Q000627:therapeutic use*; D011446:Prospective Studies; D011743:Pyrimidines / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome; D017539:Tunica Intima / Q000187:drug effects*; D017540:Tunica Media / Q000187:drug effects*; D055815:Young Adult
D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D005464:Fluorobenzenes; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D017035:Pravastatin