Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ASA group<br>Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks | Drug: Acetylsalicylic acid<br>* Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks<br>|
| Placebo Comparator: Placebo oral capsule group<br>Identical pill containing placebo, taken once daily for 04 weeks | Drug: Placebo oral capsule<br>* Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of thromboxane B2 | Measured by ELISA | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic sclerosis, Acetylsalicylic acid, Vascular dysfunction