A Phase 4 interventional study of Acetylsalicylic acid and Placebo oral capsule in Systemic Sclerosis, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 70 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
Drug: Acetylsalicylic acid
Identical pill containing placebo, taken once daily for 04 weeks
Drug: Placebo oral capsule
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
Serum level of thromboxane B2
Measured by ELISA
Time frame: Baseline and 4 weeks
Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles
Measured by flow cytometry
Time frame: Baseline and 4 weeks
Serum level of von Willebrand factor
Measured by ELISA
Time frame: Baseline and 4 weeks
Serum level of endothelin-1
Measured by ELISA
Time frame: Baseline and 4 weeks
Digital blood flow
Measured by laser Doppler imaging
Time frame: Baseline and 4 weeks
Plan to share: Undecided — Under discussion
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo