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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASA group | Active Comparator | Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks |
|
| Placebo oral capsule group | Placebo Comparator | Identical pill containing placebo, taken once daily for 04 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid | Drug | Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of thromboxane B2 | Measured by ELISA | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles | Measured by flow cytometry | Baseline and 4 weeks |
| Serum level of von Willebrand factor | Measured by ELISA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane Kayser, PhD | Federal University of São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Systemic Sclerosis Outpatient Clinic, Hospital São Paulo | São Paulo | São Paulo | Brazil |
Under discussion
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo oral capsule | Drug | Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks |
|
| Baseline and 4 weeks |
| Serum level of endothelin-1 | Measured by ELISA | Baseline and 4 weeks |
| Digital blood flow | Measured by laser Doppler imaging | Baseline and 4 weeks |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |