Subclinical Cardiovascular Disease in Psoriatic Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-04-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiovascular Diseases Myocardial Infarction Atherosclerotic Cardiovascular Disease Thrombotic Vascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psoriatic Disease Patients

Moderate to severe psoriatic disease

Group Type OTHER

Aspirin and/or Atorvastatin

Intervention Type DRUG

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

Healthy Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin and/or Atorvastatin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes