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Trial record 17 of 87 for:    ASPIRIN AND thromboxane

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

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ClinicalTrials.gov Identifier: NCT03558854
Recruitment Status : Enrolling by invitation
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Cristiane Kayser, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: Acetylsalicylic acid Drug: Placebo oral capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: ASA group
Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
Drug: Acetylsalicylic acid
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
Drug: Placebo oral capsule
Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks




Primary Outcome Measures :
  1. Serum level of thromboxane B2 [ Time Frame: Baseline and 4 weeks ]
    Measured by ELISA


Secondary Outcome Measures :
  1. Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles [ Time Frame: Baseline and 4 weeks ]
    Measured by flow cytometry

  2. Serum level of von Willebrand factor [ Time Frame: Baseline and 4 weeks ]
    Measured by ELISA

  3. Serum level of endothelin-1 [ Time Frame: Baseline and 4 weeks ]
    Measured by ELISA

  4. Digital blood flow [ Time Frame: Baseline and 4 weeks ]
    Measured by laser Doppler imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558854


Locations
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Brazil
Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
São Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Director: Cristiane Kayser, PhD Federal University of Sao Paulo

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Responsible Party: Cristiane Kayser, Principal investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03558854     History of Changes
Other Study ID Numbers: 0246/2018
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Under discussion

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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

Keywords provided by Cristiane Kayser, Federal University of São Paulo:
Systemic sclerosis
Acetylsalicylic acid
Vascular dysfunction

Additional relevant MeSH terms:
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Aspirin
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics