World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03558854
Date of registration: 03/05/2018
Prospective Registration: Yes
Primary sponsor: Federal University of São Paulo
Public title: Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
Scientific title: Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
Date of first enrolment: August 28, 2018
Target sample size: 70
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03558854
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Brazil
Contacts
Name:     Cristiane Kayser
Address: 
Telephone: 55-11-55764239
Email: cristiane.kayser@unifesp.br
Affiliation: 
Name:     Sandra Maximiano
Address: 
Telephone: 55-61-991776559
Email: sandramaximianoo@gmail.com
Affiliation: 
Name:     Cristiane Kayser, PhD
Address: 
Telephone:
Email:
Affiliation:  Federal University of Sao Paulo
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Systemic Sclerosis
Intervention(s)
Drug: Acetylsalicylic acid
Drug: Placebo oral capsule
Primary Outcome(s)
Serum level of thromboxane B2 [Time Frame: Baseline and 4 weeks]
Secondary Outcome(s)
Digital blood flow [Time Frame: Baseline and 4 weeks]
Serum level of endothelin-1 [Time Frame: Baseline and 4 weeks]
Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles [Time Frame: Baseline and 4 weeks]
Serum level of von Willebrand factor [Time Frame: Baseline and 4 weeks]
Secondary ID(s)
0246/2018
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history