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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.
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
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
Name:     Cristiane Kayser
Telephone: 55-11-55764239
Name:     Sandra Maximiano
Telephone: 55-61-991776559
Name:     Cristiane Kayser, PhD
Affiliation:  Federal University of Sao Paulo
Key inclusion & exclusion criteria

Inclusion Criteria:

- Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification

- 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
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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