Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
São Paulo, Brazil
NCT Number: NCT03558854
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
São Paulo, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Time frame: Baseline and 4 weeks
Measured by ELISA
Time frame: Baseline and 4 weeks
Measured by flow cytometry
Time frame: Baseline and 4 weeks
Measured by ELISA
Time frame: Baseline and 4 weeks
Measured by ELISA
Time frame: Baseline and 4 weeks
Measured by laser Doppler imaging
Federal University of São Paulo
Other
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
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