Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum level of thromboxane B2
研究概览
简要总结
Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria;
- •Pharmacological treatment with stable dosages for the last three months.
排除标准
- •Pregnancy;
- •Use of anticoagulants, NSAIDs or antiplatelets drugs;
- •Diagnose of other autoimmune rheumatic diseases, coronary diseases, cerebrovascular diseases and severe peripheral artery diseases;
- •Active infection;
- •Contraindication to acetylsalicylic acid use.
研究组 & 干预措施
ASA group
Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
干预措施: Acetylsalicylic acid (Drug)
Placebo oral capsule group
Identical pill containing placebo, taken once daily for 04 weeks
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Serum level of thromboxane B2
时间窗: Baseline and 4 weeks
Measured by ELISA
次要结局
- Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles(Baseline and 4 weeks)
- Serum level of endothelin-1(Baseline and 4 weeks)
- Serum level of von Willebrand factor(Baseline and 4 weeks)
- Digital blood flow(Baseline and 4 weeks)
研究者
Cristiane Kayser
Principal investigator
Federal University of São Paulo