- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558854
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
November 30, 2021 updated by: Cristiane Kayser, Federal University of São Paulo
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: ASA group
Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
|
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
|
PLACEBO_COMPARATOR: Placebo oral capsule group
Identical pill containing placebo, taken once daily for 04 weeks
|
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum level of thromboxane B2
Time Frame: Baseline and 4 weeks
|
Measured by ELISA
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles
Time Frame: Baseline and 4 weeks
|
Measured by flow cytometry
|
Baseline and 4 weeks
|
Serum level of von Willebrand factor
Time Frame: Baseline and 4 weeks
|
Measured by ELISA
|
Baseline and 4 weeks
|
Serum level of endothelin-1
Time Frame: Baseline and 4 weeks
|
Measured by ELISA
|
Baseline and 4 weeks
|
Digital blood flow
Time Frame: Baseline and 4 weeks
|
Measured by laser Doppler imaging
|
Baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Cristiane Kayser, PhD, Federal University of São Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 28, 2018
Primary Completion (ACTUAL)
September 2, 2021
Study Completion (ACTUAL)
October 26, 2021
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
June 5, 2018
First Posted (ACTUAL)
June 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 1, 2021
Last Update Submitted That Met QC Criteria
November 30, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Connective Tissue Diseases
- Sclerosis
- Scleroderma, Systemic
- Scleroderma, Diffuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 0246/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Under discussion
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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