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Trial record 17 of 92 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 : Recruiting
First Posted : June 15, 2018
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Cristiane Kayser, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE May 3, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE August 28, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Serum level of thromboxane B2 [ Time Frame: Baseline and 4 weeks ]
Measured by ELISA
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles [ Time Frame: Baseline and 4 weeks ]
    Measured by flow cytometry
  • Serum level of von Willebrand factor [ Time Frame: Baseline and 4 weeks ]
    Measured by ELISA
  • Serum level of endothelin-1 [ Time Frame: Baseline and 4 weeks ]
    Measured by ELISA
  • Digital blood flow [ Time Frame: Baseline and 4 weeks ]
    Measured by laser Doppler imaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
Official Title  ICMJE Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Sclerosis
Intervention  ICMJE
  • Drug: Acetylsalicylic acid
    Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
  • Drug: Placebo oral capsule
    Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Study Arms  ICMJE
  • Active Comparator: ASA group
    Pill containing 100 mg of acetylsalicylic acid, taken once daily for 04 weeks
    Intervention: Drug: Acetylsalicylic acid
  • Placebo Comparator: Placebo oral capsule group
    Identical pill containing placebo, taken once daily for 04 weeks
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
105
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sandra Maximiano 55-61-991776559 sandramaximianoo@gmail.com
Contact: Cristiane Kayser 55-11-991732117 cristiane.kayser@unifesp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03558854
Other Study ID Numbers  ICMJE 0246/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Under discussion
Responsible Party Cristiane Kayser, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cristiane Kayser, PhD Federal University of Sao Paulo
PRS Account Federal University of São Paulo
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP