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Subclinical Cardiovascular Disease in Psoriatic Disease

Primary Purpose

Cardiovascular Diseases, Myocardial Infarction, Atherosclerotic Cardiovascular Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aspirin and/or Atorvastatin

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring cardiovascular disease, CVD

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Psoriatic Disease Patients

Healthy Control

Arm Description

Moderate to severe psoriatic disease

Outcomes

Primary Outcome Measures

Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript

Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation

Secondary Outcome Measures

Fold Change Change in Composite Endothelial Inflammation

Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy

Fold Change in Composite Endothelial Inflammation

Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.

Change in Levels of Circulating Thromboxane B2

Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy

Full Information

NCT ID

NCT03228017

First Posted

July 11, 2017

Last Updated

August 31, 2021

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT03228017

Brief Title

Subclinical Cardiovascular Disease in Psoriatic Disease

Official Title

Subclinical Cardiovascular Disease in Psoriatic Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

April 1, 2019 (Actual)

Study Completion Date

April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, Myocardial Infarction, Atherosclerotic Cardiovascular Disease, Thrombotic Vascular Disease

Keywords

cardiovascular disease, CVD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psoriatic Disease Patients

Arm Type

Other

Arm Description

Moderate to severe psoriatic disease

Arm Title

Healthy Control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Aspirin and/or Atorvastatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript

Description

Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation

Time Frame

Baseline, 5 Months

Secondary Outcome Measure Information:

Title

Fold Change Change in Composite Endothelial Inflammation

Description

Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy

Time Frame

Baseline (pre-Aspirin), 2 weeks (post-Aspirin)

Title

Fold Change in Composite Endothelial Inflammation

Description

Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.

Time Frame

Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)

Title

Change in Levels of Circulating Thromboxane B2

Description

Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy

Time Frame

Baseline (pre-Aspirin), 2 weeks (post-Aspirin)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Berger, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35490599

Citation

Garshick MS, Block R, Drenkova K, Tawil M, James G, Brenna JT. Statin therapy upregulates arachidonic acid status via enhanced endogenous synthesis in patients with plaque psoriasis. Prostaglandins Leukot Essent Fatty Acids. 2022 May;180:102428. doi: 10.1016/j.plefa.2022.102428. Epub 2022 Apr 16.

Results Reference

derived

PubMed Identifier

32131611

Citation

Garshick MS, Tawil M, Barrett TJ, Salud-Gnilo CM, Eppler M, Lee A, Scher JU, Neimann AL, Jelic S, Mehta NN, Fisher EA, Krueger JG, Berger JS. Activated Platelets Induce Endothelial Cell Inflammatory Response in Psoriasis via COX-1. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1340-1351. doi: 10.1161/ATVBAHA.119.314008. Epub 2020 Mar 5.

Results Reference

derived

PubMed Identifier

30760013

Citation

Garshick MS, Barrett TJ, Wechter T, Azarchi S, Scher JU, Neimann A, Katz S, Fuentes-Duculan J, Cannizzaro MV, Jelic S, Fisher EA, Krueger JG, Berger JS. Inflammasome Signaling and Impaired Vascular Health in Psoriasis. Arterioscler Thromb Vasc Biol. 2019 Apr;39(4):787-798. doi: 10.1161/ATVBAHA.118.312246.

Results Reference

derived

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Subclinical Cardiovascular Disease in Psoriatic Disease

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