NCT00555230已完成2 期
Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
研究概览
简要总结
The purpose of this study is:
- To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls.
- To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness.
- To ascertain the efficacy and safety of rosuvastatin in the prevention of atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and pulse wave velocity (PWV).
详细描述
150 consecutive RA patients followed at the Rheumatology clinic of the Prince of Wales Hospital will be recruited for this double-blind, randomized, placebo-control trial. Patients were matched to 150 controls on the basis of age (within 5 years), sex, body mass index (+/-5Kg) and ethnicity for the cross sectional study on the prevalence of subclinical atherosclerosis. Controls were healthy individuals recruited from the same community who underwent similar imaging protocols of the IMT and PWV assessments.
Primary outcome is the improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
Secondary outcomes:
- Prevalence of premature atherosclerosis in RA patients compared to healthy controls in terms of the presence of plague and PWV.
- Correlation between clinical parameters, inflammatory markers (CRP/hsCRP, TNF-alpha and IL-6) and atherosclerosis (evaluated by IMT, the presence of plaque and PWV).
- Relation among PWV, ABI and AI in RA patients, and clinical significance of their combination.
- Determine which segment's PWV has a better relation with RA disease activity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, 18 years of age or older
- •Clinical diagnosis of RA with a duration of at least 6 month
- •Prednisolone < =10 mg/day
- •NSAID or DMARD
- •Informed consent
排除标准
- •Little or no ability for self-care
- •Type 1 diabetes mellitus
- •Uncontrolled hypertension(> 160/95 mmHg)
- •Total cholesterol > 240 mg/dl, current or recent (within the past 3 months)
- •History of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction < 40%), significant valvular heart disease
- •Current treatment with ACE inhibitor, angiotensin II receptor blockers or beta-blockers, lipid lowering drug, or contra-indication to statins
- •Current treatment of oral contraceptives, estrogen and progestin was allowed but patient not willing to stop during study
- •Current treatment with antioxidant therapy (Vitamin C or multivitamin)
- •Received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening
- •Clinically significant renal disease(serum creatinine level ≥ 270 µmol/L) or aspartate aminotransferase(AST), alanine aminotransferase ALT), or creatine kinase (CK)≥ 2 X ULN
- •Female of childbearing potential, unwilling to use adequate contraception during the study
- •Current or recent (within the past 3 months) pregnancy and cancer
研究组 & 干预措施
1
Experimental
Rosuvastatin
干预措施: Rosuvastatin (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
时间窗: baseline,week24,week52
次要结局
- physical examination,blood pressure,pulse rate,and body weight measurements at each visit.Liver function and CK are performed at baseline,week 12,24 and 52.Correlation between clinical parameters,inflammatory markers and atherosclerosis.(baseline,week0,week3,week8,week12,week24,week36,week52)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effects of HMG-CoA reductase inhibitor on atherosclerosis and multi-lipoprotein profiling in patients without coronary artery diseasePatients with hypercholesterolemiaJPRN-UMIN000002600agoya University Graduate School of Medicine40
已完成
不适用
The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 SecretionHydroxymethylglutaryl-CoA Reductase InhibitorsDiabetes Mellitus, Type 2NCT03018444University Hospital, Gentofte, Copenhagen15
已完成
2 期
Lipitor as a Treatment for Alzheimer's DiseaseAlzheimer DiseaseNCT00024531Institute for the Study of Aging (ISOA)98
已完成
不适用
Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target ValuesHypercholesterolaemiaNCT01483950AstraZeneca800
已完成
4 期
Vascular Effects of Ezetimibe/Simvastatin and Simvastatin on AtherosclerosisAtherosclerosisNCT00560170National Cheng-Kung University Hospital40