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

NCT ID: NCT03558854

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2021-10-26

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis

Keywords

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Systemic sclerosis Acetylsalicylic acid Vascular dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASA group

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

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type DRUG

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

Placebo oral capsule group

Identical pill containing placebo, taken once daily for 04 weeks

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

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

Interventions

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Acetylsalicylic acid

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

Intervention Type DRUG

Placebo oral capsule

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Cristiane Kayser

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristiane Kayser, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

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Systemic Sclerosis Outpatient Clinic, Hospital São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0246/2018

Identifier Type: -

Identifier Source: org_study_id