Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
- Conditions
- Systemic Sclerosis
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03558854
- Lead Sponsor
- Federal University of São Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria;
- Pharmacological treatment with stable dosages for the last three months.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo oral capsule group Placebo oral capsule Identical pill containing placebo, taken once daily for 04 weeks ASA group Acetylsalicylic acid Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
- Primary Outcome Measures
Name Time Method Serum level of thromboxane B2 Baseline and 4 weeks Measured by ELISA
- Secondary Outcome Measures
Name Time Method Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles Baseline and 4 weeks Measured by flow cytometry
Serum level of endothelin-1 Baseline and 4 weeks Measured by ELISA
Serum level of von Willebrand factor Baseline and 4 weeks Measured by ELISA
Digital blood flow Baseline and 4 weeks Measured by laser Doppler imaging
Trial Locations
- Locations (1)
Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
🇧🇷São Paulo, SP, Brazil