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

• Main Authors: Yilong Wang, Anxin Wang, Hongwei Li, Zhanquan Li, Bo Hu, Xiaogang Li, Huaguang Zheng, Lu Fu, Hongtao Hu, Zhiyu Nie, Yulin Qin, Bilian Zhao, Di Wei, Björn W. Karlson, Michiel L. Bots, Yundai Chen, Yongjun Wang
• Format: Article
• Language: English
• Published: BMC 2020-11-01
• Series: Trials
• Subjects: Chinese; METEOR-China; Study design; Subclinical atherosclerosis; Rosuvastatin; Statin
• Online Access: http://link.springer.com/article/10.1186/s13063-020-04741-0

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