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 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

Journal: Trials 2021;21(1):921

PMID: 33176842

Free Full Text on BioMed Central View on PubMed

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.

Address: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.; China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, No. 6 Tiantanxili, Dongcheng District, Beijing, 100050, China.; Department of Cardiology, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, China.; The People's Hospital of Liaoning Province, Shenyang, China.; Department of Neurology, Union Hospital of Huazhong University of Science and Technology, Wuhan, China.; Department of Neurology, Peking University Third Hospital, Beijing, China.; The First Affiliated Hospital of Harbin Medical University, Harbin, China.; Beijing Ji Shui Tan Hospital, Beijing, China.; Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai, China.; AstraZeneca R&D, Shanghai, China.; AstraZeneca R&D Gothenburg, Mölndal, Sweden.; Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.; Department of Cardiology, China PLA General Hospital, 28 Fuxing Rd., Haidian District, Beijing, 100853, China. [email protected].; Beijing Tian Tan Hospital, Capital Medical University, Beijing, China. [email protected].; China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, No. 6 Tiantanxili, Dongcheng District, Beijing, 100050, China. [email protected].

DOI: 10.1186/s13063-020-04741-0

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MeSH Terms: Atherosclerosis, Carotid Intima-Media Thickness, China, Fluorobenzenes, Humans, Pyrimidines, Rosuvastatin Calcium, Sulfonamides