A phase3 Study Measuring the Effect of Rosuvastatin 20 mg on Carotid Intima-Media Thickness in Chinese Subjects With Subclinical Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: Rosuvastatin; Placebo
Intervention description: 20mg tablets, orally once daily for the duration of the 104-week treatment period; Matching placebo tablets, orally once daily for the duration of the 104-week treatment period.
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 543.0
Sex: All
Minimum age: 45 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Rosuvastatin 20 mg treatment, Carotid Intima-Media Thickness, Chinese subjects, Subclinical atherosclerosis

Summary:

      The purpose of this study is to evaluate the effects of of rosuvastatin 20 mg compared to
      placebo for treating Chinese patients with subclinical atherosclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study-specific procedures

          -  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:

          -  Use of pharmacologic lipid-lowering medications (eg, statins, fibrate derivatives,bile
             acid binding resins, niacin, or its analogues at doses >400 mg or prescribed Chinese
             traditional drugs), including cholesterol-absorption inhibitors (CAIs), and CAI/statin
             combination, within 12 months prior to Visit 1

          -  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)