Pitavastatin on Carotid Intima-media Thickness
- Registration Number
- NCT00711919
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Diagnosed as having hyperlipidemia
- LDL-C at the time of enrollment is no less than 100
- Common carotid IMT is 1.1 mm and over
- Received or planned to receive intervention on carotid arteries during the study period
- Overt liver dysfunction (ALT; 100 IU/L and over)
- Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
- Receiving Cyclosporin
- Hyperreactive to Pitavastatin
- During pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. 2 Pitavastatin Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.
- Primary Outcome Measures
Name Time Method absolute changes in carotid intima-media thickness from baseline to final visit 12 months
- Secondary Outcome Measures
Name Time Method change in hs-CRP and IL-6 12 months change in LDL-C, HDL-C, TG and RLP-C 12 months new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans 12 months relative change in carotid intima-media thickness 12 months sudden death 12 months side effects 12 months
Trial Locations
- Locations (18)
Ayabe City Hospital
🇯🇵Ayabe, Kyoto, Japan
Tanabe Central Hospital
🇯🇵Kyotanabe, Kyoto, Japan
Maizuru Kyosai Hospital
🇯🇵Maizuru, Kyoto, Japan
Fukuchiyama City Hospital
🇯🇵Fukuchiyama, Kyoto, Japan
Maizuru Medical Center
🇯🇵Maizuru, Kyoto, Japan
Nantan General Hospital
🇯🇵Nantan, Kyoto, Japan
Omihachiman Community Medical Center
🇯🇵Omihachiman, Shiga, Japan
Kumihama Hospital
🇯🇵Kyotango, Kyoto, Japan
Saiseikai Kyoto Hospital
🇯🇵Nagaokakyo, Kyoto, Japan
Gakken Toshi Hospital
🇯🇵Seika, Kyoto, Japan
Shiga Hospital
🇯🇵Higashioumi, Shiga, Japan
Meiji University of Integrative Medicine Hospital
🇯🇵Nantan, Kyoto, Japan
Kyoto Prefectural Yosanoumi Hospital
🇯🇵Yosano, Kyoto, Japan
Uji Hospital
🇯🇵Uji, Kyoto, Japan
Saiseikai Shigaken Hospital
🇯🇵Rittou, Shiga, Japan
Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Takeda Hospital
🇯🇵Kyoto, Japan
Kyoto First Red Cross Hospital
🇯🇵Kyoto, Japan