title: Rationale and design of the carotid plaque in human for all evaluations with aggressive rosuvastatin therapy (CHALLENGER trial): evaluation by magnetic resonance imaging.
abstract: 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.
authors.affiliation: Department of Cardiovascular Medicine, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Katsumi
authors.initials: K
authors.lastname: Miyauchi
authors.forename: Norihide
authors.initials: N
authors.lastname: Takaya
authors.forename: Takahisa
authors.initials: T
authors.lastname: Hirose
authors.forename: Fuki
authors.initials: F
authors.lastname: Ikeda
authors.forename: Ryuzo
authors.initials: R
authors.lastname: Kawamori
authors.forename: Hidenori
authors.initials: H
authors.lastname: Ohishi
authors.forename: Kensaku
authors.initials: K
authors.lastname: Yoshida
authors.forename: Munetaka
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Hajime
authors.initials: H
authors.lastname: Arai
authors.forename: Takao
authors.initials: T
authors.lastname: Urabe
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Hattori
authors.forename: Michimasa
authors.initials: M
authors.lastname: Suzuki
authors.forename: Tadayuki
authors.initials: T
authors.lastname: Maehara
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sase
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Hatsukami
authors.forename: Chun
authors.initials: C
authors.lastname: Yuan
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Daida
mesh_terms: 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
chemical_list: D008078:Cholesterol, LDL; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium