NCT02117453已完成3 期
Multicenter, Prospective, Randomized, Controlled, Double-blind Trial on the Impact of Rosuvastatin on Subclinical Markers of Atherosclerosis in Patients With Primary Necrotizing Vasculitides
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Mean change from baseline in mean carotid intima-media thickness for 2 predefined sites (distal common carotid arteries)
研究概览
简要总结
The purpose of this study is to assess whether rosuvastatin could reduce the subclinical markers of atherosclerosis and the incidence of major cardiovascular events in patients with primary necrotizing vasculitides.
详细描述
Previous studies demonstrated the presence of subclinical atherosclerosis in patients with ANCA-associated systemic necrotizing vasculitis. Since statins lower levels of inflammatory proteins and cholesterol, we hypothesized that people with ANCA-associated systemic necrotizing vasculitis but without indication for statin treatment according to recommandations might benefit from statin treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient > 18 years. ANCA-associated vasculitis: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss syndrome).
- •Patients will fulfill the Chapel Hill Consensus Criteria and the American College of Rheumatology criteria, in remission of vasculitis.
- •Patients in remission of vasculitis after induction therapy (for first flare or relapse), including corticosteroids associated or not with immunosuppressive agents according to Good Clinical Practice for the treatment of vasculitis, between 6 months and 10 years after the beginning of induction therapy.
- •Patients with informed and signed consent
排除标准
- •Other systemic vasculitis. Secondary vasculitis (paraneoplastic or infectious). Patient with active vasculitis after induction therapy, requiring salvage therapy.
- •Inability to sign informed consent. Inability to take the experimental treatment. Hypersensitivity to rosuvastatin or to any of the excipients. Pregnancy. Chronic HCV, HBV and/or HIV infection. Patient receiving other statin or other hypolipemic agent. Patient requiring treatment with statin according to Afssaps recommandations published in 2005 as primary or secondary prevention.
- •Subclinical atherosclerosis that confers a high cardiovascular risk before patient randomization :
- •Carotid stenosis greater than 50% in diameter
- •Ectasia of the abdominal aorta
- •Intima-media thickening greater than 1.2 mm
- •Diffuse atherosclerosis lesions
- •Heterogeneous or hypoechoic prominent plaques greater than 2 mm
- •Participation in another interventional study within 3 months before inclusion. Sick patients will not be excluded if they participate simultaneously in a strictlu observational study or a study with only blood samplings.
- •Any medical or psycatric disease that could prevent from administrating drugs or from following-up the patient according to the protocol, and/or that would expose the patient to an important number of side effects, according to the principal investigator.
- •Non affiliation to a social security system or any social protection system.
研究组 & 干预措施
Group I
Experimental
Rosuvastatin 20 mg/day
干预措施: Rosuvastatin (Drug)
Group II
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in mean carotid intima-media thickness for 2 predefined sites (distal common carotid arteries)
时间窗: 24 months
Assessed with B-mode ultrasound
次要结局
- Mean change from baseline in serum biomarkers of subclinical atherosclerosis at 6, 12 and 24 months(24 months)
- Rate of vasculitis relapses defined by BVAS>0(24 months)
- Mean change from baseline in lipid profile (triglycerids, total, HDL and LDL cholesterol) at 6, 12 and 24 months compared to baseline value.(24 months)
- Annualized rate of change in mean carotid intima-media thickness for 2 predefined sites (distal common carotid arteries)(24 months)
- Mean change from baseline in the number of plaques in three peripheral vessels (carotid and femoral arteries and abdominal aorta) at 6, 12 and 24 months(24 months)
- Rate of major cardiovascular events (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes)(24 months)
- Rate of adverse events(24 months)
研究者
研究点 (1)
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