Subclinical Cardiovascular Disease in Psoriatic Disease

August 31, 2021 updated by: NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

63

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

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Healthy Control
Other: Psoriatic Disease Patients
Moderate to severe psoriatic disease
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript
Time Frame: Baseline, 5 Months
Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation
Baseline, 5 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fold Change Change in Composite Endothelial Inflammation
Time Frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy
Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Fold Change in Composite Endothelial Inflammation
Time Frame: Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)
Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.
Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)
Change in Levels of Circulating Thromboxane B2
Time Frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy
Baseline (pre-Aspirin), 2 weeks (post-Aspirin)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Jeffrey Berger, MD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2017

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-00692

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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