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Completed

NCT Number: NCT03228017

Subclinical Cardiovascular Disease in Psoriatic Disease

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombotic Vascular Disease Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin and/or Atorvastatin

Drug

This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2017
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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