Systemic Sclerosis
Conditions
Keywords
Systemic sclerosis, Acetylsalicylic acid, Vascular dysfunction
Brief summary
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.
Interventions
DRUGAcetylsalicylic acid
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
DRUGPlacebo oral capsule
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria; * Pharmacological treatment with stable dosages for the last three months.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum level of thromboxane B2 | Baseline and 4 weeks | Measured by ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles | Baseline and 4 weeks | Measured by flow cytometry |
| Serum level of von Willebrand factor | Baseline and 4 weeks | Measured by ELISA |
| Serum level of endothelin-1 | Baseline and 4 weeks | Measured by ELISA |
| Digital blood flow | Baseline and 4 weeks | Measured by laser Doppler imaging |
Countries
Brazil
Outcome results
None listed