Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology (TRUTH Study): rationale and design.
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.
Nozue
Tsuyoshi
T
Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital.
Yamamoto
Shingo
S
Tohyama
Shinichi
S
Umezawa
Shigeo
S
Kunishima
Tomoyuki
T
Sato
Akira
A
Miyake
Shogo
S
Takeyama
Youichi
Y
Morino
Yoshihiro
Y
Yamauchi
Takao
T
Muramatsu
Toshiya
T
Hibi
Kiyoshi
K
Sozu
Takashi
T
Michishita
Ichiro
I
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
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; D017035:Pravastatin; C108475:pitavastatin