Evaluation of the Effect of Atorvastatin and Pioglitazone in Carotid Atherosclerosis With the Use of 18Fluoride-Fludeoxyglucose(FDG) Positron Emission Tomography-computed Tomography (PET-CT)Imaging
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
研究概览
简要总结
This study is a prospective randomized clinical trial and to compare the antiinflammatory effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy in carotid arteries of stable and unstable angina patients by PET/CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject who has undergone percutaneous coronary intervention due to coronary artery disease ( stable angina or unstable angina)
- •The subject described above who has atherosclerotic plaque in his/her carotid artery by carotid ultrasonography
- •The subject who or a legal representative agrees to the clinical trial and gives written permission to the IRB-approved form.
排除标准
- •The subjets who have taken statins or thiazolidinedione with 4 weeks
- •Marked elevated liver enzyme ( more than 2.5 fold compared to reference range)
- •Renal insufficiency patients ( serum creatinine more than 2 mg/dl)
- •Congestive heart failure ( NYHA class 2-4)
- •Acue myocardial infarction
- •Unstable angina with ST segment deviation
- •Pregnancy
- •The subjects enrolled in another studies
研究组 & 干预措施
Atorvastatin 20 mg
After the subject take PET CT, he or she is randomized to either " Atorvastatin 20 mg" group or " Atorvastatin 20 mg+ Pioglitazone 30 mg". The " Atorvastatin 20 mg" group is to take atorvastatin 20 mg and take follow up PET CT in 3 months
干预措施: Atorvastatin 20mg (Drug)
Atorvastatin 20 mg + Pioglitazone 30 mg
After the subject take PET CT, he or she is randomized to either " Atorvastatin 20 mg" group or " Atorvastatin 20 mg+ Pioglitazone 30 mg". The " Atorvastatin 20 mg + Pioglitazone 30 mg" group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months
干预措施: Atorvastatin 20 mg + Pioglitazone 30 mg (Drug)
结局指标
主要结局
Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT
时间窗: 3 months
次要结局
- Difference PET CT Parameters in 3 Months Compared to Initial Evaluation(3 months)
- Difference of Laboratory Data Compared to Initial Evaluation(3 months)
- Clinical Incidents(3 months)
研究者
Eun Ho Choo
Cardiovascular Center, Seoul St. Mary's Hospital,
The Catholic University of Korea