NDLI: Rationale and design of a randomized clinical study to investigate the effect of ezetimibe, a cholesterol absorption inhibitor, on the regression of intracoronary plaque evaluated by non-obstructive angioscopy and ultrasound: The ZIPANGU study.

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Rationale and design of a randomized clinical study to investigate the effect of ezetimibe, a cholesterol absorption inhibitor, on the regression of intracoronary plaque evaluated by non-obstructive angioscopy and ultrasound: The ZIPANGU study.

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Rationale and design of a randomized clinical study to investigate the effect of ezetimibe, a cholesterol absorption inhibitor, on the regression of intracoronary plaque evaluated by non-obstructive angioscopy and ultrasound: The ZIPANGU study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Hiro, Takafumi Hirayama, Atsushi Ueda, Yasunori Komatsu, Sei Matsuoka, Hiroshi Takayama, Tadateru Ishihara, Masaharu Hayashi, Takatoshi Saito, Satoshi Kodama, Kazuhisa
Spatial Coverage	Japan
Description	Author Affiliation: Hiro T ( Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan. Electronic address: hiro.takafumi@nihon-u.ac.jp.); Hirayama A ( Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.); Ueda Y ( Cardiovascular Division, Osaka Police Hospital, Osaka, Japan.); Komatsu S ( Cardiovascular Center, Amagasaki Central Hospital, Amagasaki, Japan.); Matsuoka H ( Department of Cardiovascular Medicine, Ehime Prefectural Imabari Hospital, Imabari, Japan.); Takayama T ( Division of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.); Ishihara M ( Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center Hospital, Suita, Japan.); Hayashi T ( Hyogo Prefectural Awaji Medical Center, Sumoto, Japan.); Saito S ( Division of Cardiovascular Medicine, Keiai Hospital, Tokyo, Japan.); Kodama K ( Cardiovascular Center, Amagasaki Central Hospital, Amagasaki, Japan)
Abstract	BACKGROUND AND PURPOSE: It is well recognized that low-density lipoprotein cholesterol (LDL-C)-lowering therapy is effective for primary and secondary prevention of cerebrovascular/cardiovascular disease. Ezetimibe, an inhibitor of the Niemann-Pick C1-Like 1 cholesterol transporter, is a relatively new drug for LDL-C-lowering therapy in addition to statins. However, comparison between an aggressive LDL-C-lowering therapy with a combination of statin and ezetimibe versus a standard LDL-C-lowering therapy with statin alone is still unclear in terms of their effects on stabilization and volume regression of coronary plaque. The ZIPANGU (Ezetimibe clinical investigation for the regression of intracoronary plaque evaluated by angioscopy and ultrasound) study is aimed at comparing these two types of therapy based on indices of plaque characteristics using non-obstructive coronary angioscopy and intravascular ultrasound. METHODS: The study is a multi-center, prospective, randomized, open-label, blinded-endpoint trial. Through a centralized enrollment method, patients will be allocated to either monotherapy with atorvastatin alone or to combination therapy with atorvastatin (maximum: 20mg/day) and ezetimibe (10mg/day). The target LDL-C level will be <100mg/dL for the monotherapy group and <70mg/dL for the combination therapy group. At the baseline and the follow-up period of 9 months, non-obstructive coronary angioscopy and intravascular ultrasound will be performed to compare the changes in plaque color and volume between the two groups. CONCLUSIONS: The ZIPANGU study will clarify whether combination therapy with statins and ezetimibe is better for stabilizing coronary plaque as secondary prevention than monotherapy by statins alone. The study will give new insights into lipid-lowering guidelines in Japan.
File Format	HTM / HTML
ISSN	09145087
Issue Number	6
Volume Number	64
e-ISSN	18764738
Journal	Journal of Cardiology
Language	English
Publisher	Elsevier
Publisher Date	2014-12-01
Publisher Place	Netherlands
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Cardiology Anticholesteremic Agents Therapeutic Use Azetidines Coronary Artery Disease Drug Therapy Heptanoic Acids Hydroxymethylglutaryl-coa Reductase Inhibitors Pyrroles Administration & Dosage Atorvastatin Calcium Coronary Angiography Drug Therapy, Combination Ezetimibe Humans Japan Research Design Treatment Outcome Ultrasonography, Interventional Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Cardiology and Cardiovascular Medicine

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Rationale and design of a randomized clinical study to investigate the effect of ezetimibe, a cholesterol absorption inhibitor, on the regression of intracoronary plaque evaluated by non-obstructive angioscopy and ultrasound: The ZIPANGU study.

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Rationale and design of a randomized clinical study to investigate the effect of ezetimibe, a cholesterol absorption inhibitor, on the regression of intracoronary plaque evaluated by non-obstructive angioscopy and ultrasound: The ZIPANGU study.