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CompletedNCT00560170Updated Feb 24, 2010

Vascular Effects of Ezetimibe/Simvastatin and Simvastatin on Atherosclerosis

A Phase 4 interventional study of Simvastatin (Zocor) and 10mg/10mg of Ezetimibe/Simvastatin (Vytorin) in Atherosclerosis, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-02-24.

Sponsored by National Cheng-Kung University Hospital · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

Multiple clinical trials, using 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors (statins), have shown benefit in the primary and secondary prevention of atherosclerotic complications. However, till now, there is an incomplete understanding of all the mechanisms of the biologic effects of statins beyond LDL cholesterol (LDL-C) reduction, but there is accumulating evidence that the Rho-GTP/Rho-Kinase pathway (Rho/Rho-K) plays an important role and may be a strategic therapeutic target in cardiovascular diseases. With similar LDL-C reduction ability, the availability of Ezetimibe offers the potential to begin to address the question whether some of the benefits conferred by statins may accrue independently of their effects on LDL-C lowering. A better understanding of the role of the Rho/Rho-kinase signaling pathway in the pathogenesis of atherosclerosis in human is essential. Inhibition of Rho/Rho-kinase by statins may explain some of the biological beneficial effects of statins observed in clinical trials. This study aims to translate into patients important experimental discoveries regarding the initiation of inflammation in atherosclerosis in an attempt to improve upon the present treatment of cardiovascular diseases.

Read the detailed description

Study Design:

A single-blind controlled trial with two arms will be conducted at National Chen-Kung University Hospital (NCKUH). We will screen subjects with stable atherosclerosis to complete enrollment of 40 subjects in the study (see inclusion and exclusion criteria section below). A central pharmacist at NCKUH will randomize the patients to 40mg or Simvastatin (n=20) or 10mg/10mg of Ezetimibe/Simvastatin (n=20) for 28 days. If the patient is already on a statin a two-week washout period will be 2 weeks prior to trial initiation.

Primary Outcomes and measurement:

The primary outcomes are the mean changes in the Rho-kinase expression and activity in leukocytes in response to 40mg or Simvastatin (n=20) or 10mg/10mg of Ezetimibe/Simvastatin (n=20) over 28 days.

Secondary Outcomes and measurement:

The secondary outcomes are the correlation between the mean changes in Rho-kinase expression and activity in leukocytes and vascular tissue with the mean changes in LDL-C, hsCRP, and BAFMD, as well as its relation with clinical characteristics.

Subjects:

Participants will be recruited from the ambulatory clinics at the NCKUH Clinic.

Inclusion Criteria:

  1. Male or female subjects aged 40 to 80 years
  2. Documented stable atherosclerosis by angiography or vascular ultrasound (more that 20% luminal narrowing), peripheral arterial disease or type 2 diabetes mellitus (coronary heart disease (CHD) risk equivalent - Adult Treatment Program (ATP)-III guidelines)
  3. LDL-cholesterol >100mg/dL (indication to treat with statin)
  4. Written informed consent
  5. Primary care physician authorization letter to participate in the study.

Exclusion criteria:

  1. Inability to give consent
  2. Pre-menopausal women
  3. Current use of antibiotics, anti-inflammatory or immunosuppressant drugs
  4. History of LFT >2 times the upper normal limit
  5. History of myopathy / myositis or CPK > 10 times the upper normal limit
  6. CPK above normal limits at study onset
  7. Any evidence of inflammatory, infectious or neoplastic disease
  8. History of CABG, PCI or acute ischemic syndrome in the preceding 3 months.
02

Conditions studied

  • Atherosclerosis

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Keywords

  • HMG-CoA Reductase Inhibitors
  • endothelial function
  • HMG-CoA Reductase Inhibitors on vascular protection
03

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 40 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Inclusion Criteria:

    1. Male or female subjects aged 40 to 80 years
    2. Documented stable atherosclerosis by angiography or vascular ultrasound (more that 20% luminal narrowing), peripheral arterial disease or type 2 diabetes mellitus (coronary heart disease (CHD) risk equivalent - Adult Treatment Program (ATP)-III guidelines)
    3. LDL-cholesterol >100mg/dL (indication to treat with statin)
    4. Written informed consent
    5. Primary care physician authorization letter to participate in the study.

  • Exclusion criteria:

    1. Inability to give consent
    2. Pre-menopausal women
    3. Current use of antibiotics, anti-inflammatory or immunosuppressant drugs
    4. History of LFT >2 times the upper normal limit
    5. History of myopathy / myositis or CPK > 10 times the upper normal limit
    6. CPK above normal limits at study onset
    7. Any evidence of inflammatory, infectious or neoplastic disease
    8. History of CABG, PCI or acute ischemic syndrome in the preceding 3 months.
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    high dose statin

    40mg of Simvastatin (n=20)

    Drug: Simvastatin (Zocor)

  • Active comparator
    combination arm

    10mg/10mg of Ezetimibe/Simvastatin (n=20)

    Drug: 10mg/10mg of Ezetimibe/Simvastatin (Vytorin)

Interventions

  • DrugSimvastatin (Zocor)

    40mg of Simvastatin (n=20) orally per-day for 28 days

    Also known as: Zocor

  • Drug10mg/10mg of Ezetimibe/Simvastatin (Vytorin)

    10mg/10mg of Ezetimibe/Simvastatin (n=20) orally per-day for 28 days

    Also known as: Vytorin

06

What researchers measure

Primary outcomes

  1. changes in the lipid profile change and Rho-kinase expression and activity

    Time frame: 28 days

Secondary outcomes

  1. correlation between changes in Rho-kinase expression and activity with the changes in LDL-C, hsCRP and BAFMD

    Time frame: 28 days

07

Study locations

1 site
  • National Cheng Kung University Hospital
    Tainan, 704, Taiwan
08

References and documents

Publications

  • Liu PY, Liu YW, Lin LJ, Chen JH, Liao JK. Evidence for statin pleiotropy in humans: differential effects of statins and ezetimibe on rho-associated coiled-coil containing protein kinase activity, endothelial function, and inflammation. Circulation. 2009 Jan 6;119(1):131-8. doi: 10.1161/CIRCULATIONAHA.108.813311. Epub 2008 Dec 15. PubMed 19075102 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00560170
Lead sponsor
National Cheng-Kung University Hospital
First posted
Nov 19, 2007
Start date
Sep 2007
Primary completion
Jan 2008
Completion
Feb 2008
Last update
Feb 24, 2010

Study contacts

Jyh-Hong Chen, MD, PhD
principal investigator · National Cheng-Kung University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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