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OpenTrials
Completed

NCT Number: NCT03558854

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Systemic Sclerosis Outpatient Clinic, Hospital São Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetylsalicylic acid

Drug

Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks

Placebo oral capsule

Drug

Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks

Primary outcomes

  1. Serum level of thromboxane B2

    Time frame: Baseline and 4 weeks

    Measured by ELISA

Secondary outcomes

  1. Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles

    Time frame: Baseline and 4 weeks

    Measured by flow cytometry

  2. Serum level of von Willebrand factor

    Time frame: Baseline and 4 weeks

    Measured by ELISA

  3. Serum level of endothelin-1

    Time frame: Baseline and 4 weeks

    Measured by ELISA

  4. Digital blood flow

    Time frame: Baseline and 4 weeks

    Measured by laser Doppler imaging

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2018
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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