NCT03558854

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

May 3, 2018

Last Update Submit

November 30, 2021

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosisAcetylsalicylic acidVascular dysfunction

Outcome Measures

Primary Outcomes (1)

  • Serum level of thromboxane B2

    Measured by ELISA

    Baseline and 4 weeks

Secondary Outcomes (4)

  • Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles

    Baseline and 4 weeks

  • Serum level of von Willebrand factor

    Baseline and 4 weeks

  • Serum level of endothelin-1

    Baseline and 4 weeks

  • Digital blood flow

    Baseline and 4 weeks

Study Arms (2)

ASA group

ACTIVE COMPARATOR

Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks

Drug: Acetylsalicylic acid

Placebo oral capsule group

PLACEBO COMPARATOR

Identical pill containing placebo, taken once daily for 04 weeks

Drug: Placebo oral capsule

Interventions

Acetylsalicylic acidDRUG

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

ASA group
Placebo oral capsuleDRUG

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

Placebo oral capsule group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria;
  • Pharmacological treatment with stable dosages for the last three months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Systemic Sclerosis Outpatient Clinic, Hospital São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Cristiane Kayser, PhD

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 3, 2018

First Posted

June 15, 2018

Study Start

August 28, 2018

Primary Completion

September 2, 2021

Study Completion

October 26, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations

BR(1)