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Subclinical Cardiovascular Disease in Psoriatic Disease

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NYU Langone Health

Status and phase

Completed
Phase 4

Conditions

Atherosclerotic Cardiovascular Disease
Thrombotic Vascular Disease
Myocardial Infarction
Cardiovascular Diseases

Treatments

Drug: Aspirin and/or Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03228017
17-00692

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

Psoriatic Disease Patients
Other group
Description:
Moderate to severe psoriatic disease
Treatment:
Drug: Aspirin and/or Atorvastatin
Healthy Control
No Intervention group

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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