Vascular Effects of Ezetimibe/Simvastatin and Simvastatin on Atherosclerosis
|Atherosclerosis||Drug: Simvastatin (Zocor) Drug: 10mg/10mg of Ezetimibe/Simvastatin (Vytorin)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Rho-kinase in Patients With Atherosclerosis: Effects of Statins A Randomized Clinical Trial Comparing Ezetimibe/Simvastatin and Simvastatin|
- changes in the lipid profile change and Rho-kinase expression and activity [ Time Frame: 28 days ]
- correlation between changes in Rho-kinase expression and activity with the changes in LDL-C, hsCRP and BAFMD [ Time Frame: 28 days ]
|Study Start Date:||September 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: high dose statin
40mg of Simvastatin (n=20)
Drug: Simvastatin (Zocor)
40mg of Simvastatin (n=20) orally per-day for 28 days
Other Name: Zocor
Active Comparator: combination arm
10mg/10mg of Ezetimibe/Simvastatin (n=20)
Drug: 10mg/10mg of Ezetimibe/Simvastatin (Vytorin)
10mg/10mg of Ezetimibe/Simvastatin (n=20) orally per-day for 28 days
Other Name: Vytorin
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.
Participants will be recruited from the ambulatory clinics at the NCKUH Clinic.
- Male or female subjects aged 40 to 80 years
- 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)
- LDL-cholesterol >100mg/dL (indication to treat with statin)
- Written informed consent
- Primary care physician authorization letter to participate in the study.
- Inability to give consent
- Pre-menopausal women
- Current use of antibiotics, anti-inflammatory or immunosuppressant drugs
- History of LFT >2 times the upper normal limit
- History of myopathy / myositis or CPK > 10 times the upper normal limit
- CPK above normal limits at study onset
- Any evidence of inflammatory, infectious or neoplastic disease
- History of CABG, PCI or acute ischemic syndrome in the preceding 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560170
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 704|
|Principal Investigator:||Jyh-Hong Chen, MD, PhD||National Cheng-Kung University Hospital|