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
单位:[1]Beijing Tian Tan Hospital, Capital Medical University, Beijing, China首都医科大学附属天坛医院[2]ChinaNational Clinical Research Center for Neurological Diseases, Beijing TiantanHospital, Capital Medical University, No.6 Tiantanxili, Dongcheng District,Beijing 100050, China[3]Department of Cardiology, Beijing Friendship HospitalAffiliated to Capital Medical University, Beijing, China临床科室心血管中心心内科首都医科大学附属北京友谊医院[4]The People’s Hospitalof Liaoning Province, Shenyang, China[5]Department of Neurology, UnionHospital of Huazhong University of Science and Technology, Wuhan, China[6]Department of Neurology, Peking University Third Hospital, Beijing, China[7]The First Affiliated Hospital of Harbin Medical University, Harbin, China[8]Beijing Ji Shui Tan Hospital, Beijing, China[9]Department of Neurology,Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai,China[10]AstraZeneca R&D, Shanghai, China[11]AstraZeneca R&D Gothenburg,Mölndal, Sweden[12]Department of Molecular and Clinical Medicine,Institution of Medicine, Sahlgrenska Academy, University of Gothenburg,Gothenburg, Sweden[13]Julius Center for Health Sciences and Primary Care,University Medical Center Utrecht, Utrecht University, Utrecht, TheNetherlands[14]Department of Cardiology, China PLA General Hospital, 28Fuxing Rd,Haidian District, Beijing 100853, China
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 40mg 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 20mg 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 20mg or placebo for 104weeks. 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 20mg slows the progression of CIMT in asymptomatic Chinese subjects at low risk of ICVD.Trial registrationClinicalTrials.gov NCT02546323. Registered on September 10, 2015
第一作者单位:[1]Beijing Tian Tan Hospital, Capital Medical University, Beijing, China[2]ChinaNational Clinical Research Center for Neurological Diseases, Beijing TiantanHospital, Capital Medical University, No.6 Tiantanxili, Dongcheng District,Beijing 100050, China
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通讯作者:
通讯机构:[1]Beijing Tian Tan Hospital, Capital Medical University, Beijing, China[2]ChinaNational Clinical Research Center for Neurological Diseases, Beijing TiantanHospital, Capital Medical University, No.6 Tiantanxili, Dongcheng District,Beijing 100050, China
推荐引用方式(GB/T 7714):
Yilong Wang,Anxin Wang,Hongwei Li,et al.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[J].TRIALS.2020,21(1):doi:10.1186/s13063-020-04741-0.
APA:
Yilong Wang,Anxin Wang,Hongwei Li,Zhanquan Li,Bo Hu...&Yongjun Wang.(2020).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,21,(1)
MLA:
Yilong Wang,et al."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 21..1(2020)