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

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Acetylsalicylic acid
Placebo oral capsule
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring Systemic sclerosis, Acetylsalicylic acid, Vascular dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Systemic Sclerosis Outpatient Clinic, Hospital São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ASA group

Placebo oral capsule group

Arm Description

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

Identical pill containing placebo, taken once daily for 04 weeks

Outcomes

Primary Outcome Measures

Serum level of thromboxane B2
Measured by ELISA

Secondary Outcome Measures

Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles
Measured by flow cytometry
Serum level of von Willebrand factor
Measured by ELISA
Serum level of endothelin-1
Measured by ELISA
Digital blood flow
Measured by laser Doppler imaging

Full Information

First Posted
May 3, 2018
Last Updated
November 30, 2021
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03558854
Brief Title
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
Official Title
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
September 2, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
Systemic sclerosis, Acetylsalicylic acid, Vascular dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASA group
Arm Type
Active Comparator
Arm Description
Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
Arm Title
Placebo oral capsule group
Arm Type
Placebo Comparator
Arm Description
Identical pill containing placebo, taken once daily for 04 weeks
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Intervention Description
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Primary Outcome Measure Information:
Title
Serum level of thromboxane B2
Description
Measured by ELISA
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles
Description
Measured by flow cytometry
Time Frame
Baseline and 4 weeks
Title
Serum level of von Willebrand factor
Description
Measured by ELISA
Time Frame
Baseline and 4 weeks
Title
Serum level of endothelin-1
Description
Measured by ELISA
Time Frame
Baseline and 4 weeks
Title
Digital blood flow
Description
Measured by laser Doppler imaging
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristiane Kayser, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Under discussion

Learn more about this trial

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

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