Measuring effects on intima-media thickness: an evaluation of rosuvastatin in Chinese subjects with subclinical atherosc
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METHODOLOGY
Open Access
Measuring effects on intima-media thickness: an evaluation of rosuvastatin in Chinese subjects with subclinical atherosclerosis—design, rationale, and methodology of the METEOR-China study Yilong Wang1,2†, Anxin Wang1,2†, Hongwei Li3, Zhanquan Li4, Bo Hu5, Xiaogang Li6, Huaguang Zheng1,2, Lu Fu7, Hongtao Hu8, Zhiyu Nie9, Yulin Qin10, Bilian Zhao10, Di Wei10, Björn W. Karlson11,12, Michiel L. Bots13, Yundai Chen14* and Yongjun Wang1,2*
Abstract Background: The beneficial effect of statins on atherosclerosis and cardiovascular outcomes has been well established. The Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin (METEOR) global study demonstrated that a 2-year orally administered treatment with rosuvastatin 40 mg daily significantly slowed the progression of carotid intima-media thickness (CIMT) compared to placebo. The current METEOR-China study is designed to evaluate the effect of rosuvastatin 20 mg daily versus placebo on the progression of atherosclerosis measured by CIMT in asymptomatic Chinese subjects. Methods: This is a phase 3, randomised, double-blind, placebo-controlled, multicentre parallel-group study. Asymptomatic Chinese subjects with a 10-year ischaemic cardiovascular disease (ICVD) risk < 10% will be recruited at 25 study sites. They will be treated with rosuvastatin 20 mg or placebo for 104 weeks. The primary endpoint is the annualised rate of change in CIMT measured by B-mode ultrasonography. Secondary endpoints include the annualised rate of change in CIMT at three different sections of the carotid artery and changes in the serum lipid profile. Safety parameters will also be assessed. Conclusion: The study will evaluate whether rosuvastatin 20 mg slows the progression of CIMT in asymptomatic Chinese subjects at low risk of ICVD. Trial registration: ClinicalTrials.gov NCT02546323. Registered on September 10, 2015 Keywords: Chinese, METEOR-China, Study design, Subclinical atherosclerosis, Rosuvastatin, Statin, Carotid intimamedia thickness
* Correspondence: [email protected]; [email protected] † Wang Yilong and Wang Anxin contributed equally to this work. 14 Department of Cardiology, China PLA General Hospital, 28 Fuxing Rd., Haidian District, Beijing 100853, China 1 Beijing Tian Tan Hospital, Capital Medical University, Beijing, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your inten
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