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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558854
• Other study ID #: 0246/2018
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2018
• Est. completion date: October 26, 2021

Study information

• Verified date: November 2021
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 26, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Acetylsalicylic acid
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
• Placebo oral capsule
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks

Locations

Country	Name	City	State
Brazil	Systemic Sclerosis Outpatient Clinic, Hospital São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of thromboxane B2	Measured by ELISA	Baseline and 4 weeks
Secondary	Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles	Measured by flow cytometry	Baseline and 4 weeks
Secondary	Serum level of von Willebrand factor	Measured by ELISA	Baseline and 4 weeks
Secondary	Serum level of endothelin-1	Measured by ELISA	Baseline and 4 weeks
Secondary	Digital blood flow	Measured by laser Doppler imaging	Baseline and 4 weeks