NCT02378064已完成4 期
Comparison of Fimasartan Versus Amlodipine Therapy on Carotid PlaquE Inflammation
CHEOL WHAN LEE, M.D., Ph.D1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change (follow-up minus baseline) in standardized FDG uptake value
研究概览
简要总结
The purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial FDG PET/CT imaging of carotid artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Men or Women at least 18 years of age inclusive
- •Patients with acute coronary syndromes or unstable angina pectoris
- •Hypertension or blood pressure more than 140/90mmHg
- •FDG PET/CT shows at least 1 hot uptakes at carotid and or ascending aorta
- •The patient or guardian agrees to the study protocol and the schedule of clinical and FDG PET/CT follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Patients treated with carotid endarterectomy or stent placement
- •Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
- •Untreated hyperthyroidism, or hypothyroidism
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •Evidence of congestive heart failure, or left ventricular ejection fraction < 40%.
- •Significant renal disease manifested by serum creatinine > 2.0mg/dL, or creatinine clearance of < 40 ml/min (by Cockcroft-Gault method).
- •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- •History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
- •Unwillingness or inability to comply with the procedures described in this protocol.
- •Patient's pregnant or breast-feeding or child-bearing potential.
- •Type I Diabetes
研究组 & 干预措施
Fimasartan and vytorin
Experimental
fimasartan(60mg,QD)+Vytorin(10mg,QD)
干预措施: 6-month treatment (Drug)
Fimasartan and rosuvastatin
Experimental
fimasartan(60mg,QD)+rosuvastatin(5mg,QD)
干预措施: 6-month treatment (Drug)
amlodipine and vytorin
Active Comparator
amlodipine(5mg,QD)+Vytorin(10mg,QD)
干预措施: 6-month treatment (Drug)
amlodipine and rosuvastatin
Active Comparator
amlodipine(5mg,QD+rosuvastatin(5mg,QD)
干预措施: 6-month treatment (Drug)
结局指标
主要结局
change (follow-up minus baseline) in standardized FDG uptake value
时间窗: 6month
change (follow-up minus baseline) in standardized FDG uptake value within the regions of interest, known as a target-to-background ratio (blood-normalized standardized uptake value).
次要结局
- changes of blood pressure(6month)
- Serial changes of lipid battery(6month)
研究者
CHEOL WHAN LEE, M.D., Ph.D
professor
Asan Medical Center
研究点 (1)
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