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Subclinical Cardiovascular Disease in Psoriatic Disease

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ClinicalTrials.gov Identifier: NCT03228017
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 24, 2017
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
Brachial artery reactivity [ Time Frame: 5 Months ]
a measure of endothelial dysfunction as assessed through Nf-KB staining obtained through endothelial cell harvesting.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • Baseline endothelial vein transcriptome data [ Time Frame: 5 Months ]
    Using paired t- tests will assess the changes in endothelial function with the use of aspirin, aspirin plus atorvastatin or atorvastatin therapy.
  • Genetic expression for VCAM-1 [ Time Frame: 5 Months ]
    Untargeted RNA-sequencing will also be performed for untargeted analysis to identify novel markers of psoriatic disease and activity.
  • Genetic expression for ICAM-1 [ Time Frame: 5 Months ]
    Untargeted RNA-sequencing will also be performed for untargeted analysis to identify novel markers of psoriatic disease and activity.
  • Platelet reactivity with the use of aspirin [ Time Frame: 5 Months ]
    Platelet function assay that measures multiple platelet functions
  • Endothelial function with the use of aspirin [ Time Frame: 5 Months ]
    Extrapolating this measurement with an n = 40 for psoriatic disease and n = 10 for controls gives us > 90% power to detect baseline endothelial function differences between groups with an alpha level of 0.05 (G*Power 3.1.9.2).
  • Platelet reactivity with the use of aspirin plus atorvastatin [ Time Frame: 5 Months ]
    Platelet function assay that measures multiple platelet functions
  • Endothelial function with the use of aspirin plus atorvastatin [ Time Frame: 5 Months ]
    Extrapolating this measurement with an n = 40 for psoriatic disease and n = 10 for controls gives us > 90% power to detect baseline endothelial function differences between groups with an alpha level of 0.05 (G*Power 3.1.9.2).
  • Platelet reactivity with the use of atorvastatin therapy. [ Time Frame: 5 Months ]
    Platelet function assay that measures multiple platelet functions
  • Endothelial function with the use of atorvastatin therapy. [ Time Frame: 5 Months ]
    Extrapolating this measurement with an n = 40 for psoriatic disease and n = 10 for controls gives us > 90% power to detect baseline endothelial function differences between groups with an alpha level of 0.05 (G*Power 3.1.9.2).
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 Subclinical Cardiovascular Disease in Psoriatic Disease
Official Title  ICMJE Subclinical Cardiovascular Disease in Psoriatic Disease
Brief Summary This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. 2) Evaluate the association between moderate to severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional medications used in cardiovascular disease (CVD) prevention such as aspirin and statins affect vascular function and thrombotic risk in those with moderate to severe psoriatic disease.
Detailed Description Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate who to treat with primary prevention measures but do not take into account patient-specific disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of atherosclerotic heart disease and myocardial infarctions compared to matched controls.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Myocardial Infarction
  • Atherosclerotic Cardiovascular Disease
  • Thrombotic Vascular Disease
Intervention  ICMJE Drug: Aspirin and/or Atorvastatin
This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
Study Arms  ICMJE
  • Psoriatic Disease Patients
    Moderate to severe psoriatic disease
    Intervention: Drug: Aspirin and/or Atorvastatin
  • No Intervention: Healthy Control
Publications *

*   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: July 19, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a history of moderate to severe psoriatic disease
  • Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease

Exclusion Criteria:

  • Unable to speak Spanish or English
  • Active smoking (within the past year)
  • Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic arthritis
  • Known active cancer receiving treatment
  • Pregnancy
  • Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600)
  • A history of severe bleeding or bleeding disorders
  • Current medication use which interact with either aspirin or atorvastatin
  • Chronic kidney disease (CrCl < 30ml/min)
  • Congestive heart failure
  • Currently taking aspirin or a statin.
  • NSAID use within the past 48 hours
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michael Garshick, MD 212 263 4004 Michael.Garshick@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03228017
Other Study ID Numbers  ICMJE 17-00692
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Berger, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date January 2020

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