ClinicalTrials.Veeva

Menu

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

F

Federal University of São Paulo

Status and phase

Completed
Phase 4

Conditions

Systemic Sclerosis

Treatments

Drug: Acetylsalicylic acid
Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT03558854
0246/2018

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups, including a placebo group

ASA group
Active Comparator group
Description:
Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
Treatment:
Drug: Acetylsalicylic acid
Placebo oral capsule group
Placebo Comparator group
Description:
Identical pill containing placebo, taken once daily for 04 weeks
Treatment:
Drug: Placebo oral capsule

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems