Rationale and design of the carotid plaque in human for all evaluations with aggressive rosuvastatin therapy (CHALLENGER trial): evaluation by magnetic resonance imaging.
BACKGROUND
Intensive lipid-lowering therapy with statins reduces levels of low-density lipoprotein (LDL)-cholesterol (C) and improves plaque volume and composition in patients with cardiovascular disease. Furthermore, rosuvastatin ameliorated carotid stenosis in the ASTEROID study, and altered the composition of plaques in a predominantly Caucasian study population in the ORION study. However, it is not known whether statin therapy achieves similar quantitative improvement in carotid artery plaque in other ethnic groups.


RESULTS
Fifty patients with hypercholesterolemia (LDL-C >or=120 mg/dl) and a maximum carotid intima-media thickness >or=1.8 mm will be enrolled and treated with rosuvastatin at a dose of 5 mg/day for 96 weeks. The primary endpoints will be the percent change of carotid plaque volume and the change in plaque composition after 96 weeks of treatment, as evaluated by magnetic resonance imaging.


CONCLUSIONS
The CHALLENGER study will provide a noninvasive assessment of the changes in carotid plaque volume and composition achieved by reduction of LDL levels in Japanese patients with carotid stenosis on long-term rosuvastatin therapy.
Miyauchi
Katsumi
K
Department of Cardiovascular Medicine, Juntendo University School of Medicine, Tokyo, Japan.
Takaya
Norihide
N
Hirose
Takahisa
T
Ikeda
Fuki
F
Kawamori
Ryuzo
R
Ohishi
Hidenori
H
Yoshida
Kensaku
K
Yamamoto
Munetaka
M
Arai
Hajime
H
Urabe
Takao
T
Hattori
Nobutaka
N
Suzuki
Michimasa
M
Maehara
Tadayuki
T
Sase
Kazuhiro
K
Hatsukami
Thomas S
TS
Yuan
Chun
C
Daida
Hiroyuki
H
D000792:Angiography; D016893:Carotid Stenosis / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology*; D008078:Cholesterol, LDL / Q000097:blood; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination; D005464:Fluorobenzenes / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology*; D007564:Japan; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging; D011743:Pyrimidines / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*; D017539:Tunica Intima / Q000473:pathology; D017540:Tunica Media / Q000473:pathology
D008078:Cholesterol, LDL; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium