Subclinical Cardiovascular Disease in Psoriatic Disease

Phase 4

Completed

• Conditions: Myocardial Infarction; Atherosclerotic Cardiovascular Disease; Thrombotic Vascular Disease; Cardiovascular Diseases
• Interventions: Drug: Aspirin and/or Atorvastatin

• Registration Number: NCT03228017
• Lead Sponsor: NYU Langone Health

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 Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-24
• Study Start: 2017-08-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Results First Submitted: 2021-03-05
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-31
• Last Update Submitted: 2021-08-31
• Results First Posted: 2021-09-28
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psoriatic Disease Patients	Aspirin and/or Atorvastatin	Moderate to severe psoriatic disease

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fold Change Change in Composite Endothelial Inflammation	Baseline (pre-Aspirin), 2 weeks (post-Aspirin)	Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy
Fold Change in Composite Endothelial Inflammation	Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)	Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.
Change in Levels of Circulating Thromboxane B2	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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States