Vascular Effects of Ezetimibe/Simvastatin and Simvastatin on Atherosclerosis
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|ClinicalTrials.gov Identifier: NCT00560170|
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : February 24, 2010
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Drug: Simvastatin (Zocor) Drug: 10mg/10mg of Ezetimibe/Simvastatin (Vytorin)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (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|
|Study Start Date :||September 2007|
|Primary Completion Date :||January 2008|
|Study Completion Date :||February 2008|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560170
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 704|
|Principal Investigator:||Jyh-Hong Chen, MD, PhD||National Cheng-Kung University Hospital|