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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

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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 [3]Department of Cardiology, Beijing Friendship HospitalAffiliated to Capital Medical University, Beijing, China [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
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关键词: Chinese METEOR-China Study design Subclinical atherosclerosis Rosuvastatin Statin Carotid intima-media thickness

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 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

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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出版当年[2018]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

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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
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