A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
NCT ID: NCT02546323
Last Updated: 2019-12-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
543 participants
INTERVENTIONAL
2015-09-17
2019-01-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rosuvastatin
20 mg tablets, Daily oral dose
Rosuvastatin
20mg tablets, orally once daily for the duration of the 104-week treatment period
Placebo
Matching placebo tablets
Placebo
Matching placebo tablets, orally once daily for the duration of the 104-week treatment period.
Interventions
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Rosuvastatin
20mg tablets, orally once daily for the duration of the 104-week treatment period
Placebo
Matching placebo tablets, orally once daily for the duration of the 104-week treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male aged ≥45 and \<70 years or female aged ≥55 and \<70 years
* Subjects with only hypertension (as defined blood pressure ≥140/90 mmHg or on antihypertensive treatment) and age as CVD risk factors and subjects without hypertension who have 3 or more other risk factors (including age) must have "Fasting LDL C of ≥120 mg/dL (3.1 mmol/L) and \<160 mg/dL (4.1mmol/L)"; Subjects without hypertension who have fewer than 3 other risk factors (including age) must have "Fasting LDL-C of ≥120 mg/dL (3.1 mmol/L) and \<190 mg/dL (4.9 mmol/L)"
* Triglycerides \<500 mg/dL (5.65 mmol/L) at Visit 1
* HDL-C levels ≤60 mg/dL (1.6 mmol/L) at Visit 1
* Maximum IMT ≥1.2 mm and \<3.5 mm at any location in the carotid ultrasound scans conducted at both Visit 2 and Visit 3
* Willing to follow all study procedures including study visits, fasting blood draws, and compliance with study treatment regimen
Exclusion Criteria
* Current or recent (within 2 weeks of Visit 1) use of supplements known to alter lipid metabolism (eg, soluble fibers \[including \>2 teaspoons Metamucil® or psyllium-containing supplement per day\] or other dietary fiber supplements, marine oils, sterol/stanol products, or other supplement determined at the discretion of the investigator)
* History of hypersensitivity reactions to other HMG-CoA reductase inhibitors
* Pregnant women, women who are breast-feeding, and women of childbearing potential who are not using chemical or mechanical contraception or who have a positive serum pregnancy test
* Clinical evidence of coronary artery disease (CAD) or any other atherosclerotic disease such as angina, MI, transient ischemic attack, symptomatic CAD, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, peripheral arterial disease, abdominal aortic aneurysm
* History of cancer (other than basal cell carcinoma) in the past 2 years
* Uncontrolled hypertension defined as either a mean resting diastolic blood pressure of ≥110 mmHg or a resting systolic blood pressure of ≥180 mmHg recorded at any time during the screening period
* History of diabetes mellitus or current diabetes mellitus
* Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH) \>1.5 times the upper limit of normal (ULN) at Visit 1 or subjects whose thyroid replacement therapy was initiated within the last 3 months
* History of heterozygous or homozygous familial hypercholesterolemia or known hyperlipoproteinemia Types I, III, IV, or V (familial dysbetalipoproteinemia)
* Use of the disallowed concomitant medications within 12 months prior to Visit 1
* History of alcohol and/or drug abuse within the past 5 years
* Active liver disease or hepatic dysfunction as defined by elevations of ≥1.5 x ULN at Visit 1 in any of the following liver function tests: ALT, AST or bilirubin
* Serum creatine kinase (CK) \>3 x ULN at Visit 1
* Serum creatinine \>2.0 mg/dL (177 mmol/L) recorded during the screening period
* Participation in another investigational drug study, and having ingested investigational drug ≤4 weeks before enrollment in the screening period
* Previous randomization in the present study
* History of a significant medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
45 Years
69 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Yongjun Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tian Tan Hospital, Capital Medical University
Yundai Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Bengbu, , China
Research Site
Changsha, , China
Research Site
Chongqin, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Haerbin, , China
Research Site
Nanchang, , China
Research Site
Nanjing, , China
Research Site
Ningbo, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Tianjin, , China
Research Site
Wenzhou, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Countries
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References
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Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
Zheng H, Li H, Wang Y, Li Z, Hu B, Li X, Fu L, Hu H, Nie Z, Zhao B, Wei D, Karlson BW, Bots ML, Meng X, Chen Y, Wang Y; METEOR-China Investigators. Rosuvastatin Slows Progression of Carotid Intima-Media Thickness: The METEOR-China Randomized Controlled Study. Stroke. 2022 Oct;53(10):3004-3013. doi: 10.1161/STROKEAHA.120.031877. Epub 2022 Aug 26.
Wang Y, Wang A, Li H, Li Z, Hu B, Li X, Zheng H, Fu L, Hu H, Nie Z, Qin Y, Zhao B, Wei D, Karlson BW, Bots ML, Chen Y, Wang Y. 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. 2020 Nov 11;21(1):921. doi: 10.1186/s13063-020-04741-0.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D3565C00003
Identifier Type: -
Identifier Source: org_study_id