title: Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology (TRUTH Study): rationale and design.
abstract: BACKGROUND
  Many clinical trials have shown that 3-hydroxy-3-methylglutaryl-conenzyme A reductase inhibitors (statins) can significantly reduce the incidence of coronary artery disease in both primary and secondary prevention. A recent study showed that aggressive lipid-lowering therapy with statins could achieve regression of coronary artery plaque evaluated with gray-scale intravascular ultrasound (IVUS). However, the actual changes in coronary artery plaque composition produced by statin therapy have not been well delineated.
  
  
  RESULTS
  This study will be a prospective, open-label, randomized multicenter study of 160 patients with stable or unstable angina who have undergone percutaneous coronary intervention with Virtual Histology IVUS (VH-IVUS). Patients will be randomly assigned to either the pitavastatin or pravastatin group. After treatment for 24-40 weeks, VH-IVUS will be performed again in the same segment of the coronary artery. The primary endpoint will be quantitative changes in each of the 4 components measured by VH-IVUS.
  
  
  CONCLUSIONS
  The treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology (TRUTH) study will be the first multicenter study using VH-IVUS to evaluate the effects of statins on changes in coronary artery plaque composition and the findings will clarify the mechanisms of coronary artery plaque stabilization.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Nozue
authors.forename: Shingo
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Shinichi
authors.initials: S
authors.lastname: Tohyama
authors.forename: Shigeo
authors.initials: S
authors.lastname: Umezawa
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Kunishima
authors.forename: Akira
authors.initials: A
authors.lastname: Sato
authors.forename: Shogo
authors.initials: S
authors.lastname: Miyake
authors.forename: Youichi
authors.initials: Y
authors.lastname: Takeyama
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.forename: Takao
authors.initials: T
authors.lastname: Yamauchi
authors.forename: Toshiya
authors.initials: T
authors.lastname: Muramatsu
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Hibi
authors.forename: Takashi
authors.initials: T
authors.lastname: Sozu
authors.forename: Ichiro
authors.initials: I
authors.lastname: Michishita
mesh_terms: D050197:Atherosclerosis / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D023381:Endpoint Determination; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D017035:Pravastatin / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D011804:Quinolines / Q000009:adverse effects / Q000627:therapeutic use; D018084:Ultrasonography, Interventional; D014584:User-Computer Interface
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D017035:Pravastatin; C108475:pitavastatin