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

Trials

Björn W. Karlson¹  Yulin Qin²  Bilian Zhao²  Di Wei²  Hongtao Hu³  Huaguang Zheng⁴  Anxin Wang⁴  Yilong Wang⁴  Yongjun Wang⁴  Hongwei Li⁵  Yundai Chen⁶  Xiaogang Li⁷  Zhiyu Nie⁸  Bo Hu⁹  Michiel L. Bots^1,10  Lu Fu^1,11  Zhanquan Li^1,12 

[1] AstraZeneca R&D Gothenburg, Mölndal, Sweden;Department of Molecular and Clinical Medicine, Institution of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden;AstraZeneca R&D, Shanghai, China;Beijing Ji Shui Tan Hospital, Beijing, China;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, 100050, Beijing, China;Department of Cardiology, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing, China;Department of Cardiology, China PLA General Hospital, 28 Fuxing Rd., Haidian District, 100853, Beijing, China;Department of Neurology, Peking University Third Hospital, Beijing, China;Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai, China;Department of Neurology, Union Hospital of Huazhong University of Science and Technology, Wuhan, China;Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands;The First Affiliated Hospital of Harbin Medical University, Harbin, China;The People’s Hospital of Liaoning Province, Shenyang, China;

关键词: Chinese;    METEOR-China;    Study design;    Subclinical atherosclerosis;    Rosuvastatin;    Statin;    Carotid intima-media thickness;   

DOI  :  10.1186/s13063-020-04741-0

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsThis 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.ConclusionThe study will evaluate whether rosuvastatin 20 mg slows the progression of CIMT in asymptomatic Chinese subjects at low risk of ICVD.Trial registrationClinicalTrials.gov NCT02546323. Registered on September 10, 2015

【 授权许可】

CC BY