Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology (TRUTH Study): rationale and design - PubMed (original) (raw)

Randomized Controlled Trial

doi: 10.1253/circj.cj-08-0593. Epub 2008 Dec 26.

Shingo Yamamoto, Shinichi Tohyama, Shigeo Umezawa, Tomoyuki Kunishima, Akira Sato, Shogo Miyake, Youichi Takeyama, Yoshihiro Morino, Takao Yamauchi, Toshiya Muramatsu, Kiyoshi Hibi, Takashi Sozu, Ichiro Michishita; Kanagawa PTCA Conference Study Group

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Free article

Randomized Controlled Trial

Treatment with statin on atheroma regression evaluated by intravascular ultrasound with Virtual Histology (TRUTH Study): rationale and design

Tsuyoshi Nozue et al. Circ J. 2009 Feb.

Free article

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.

Methods and 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.

Conclusion: 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.

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