Subclinical Cardiovascular Disease in Psoriatic Disease

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03228017
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases; Myocardial Infarction; Atherosclerotic Cardiovascular Disease; Thrombotic Vascular Disease	Drug: Aspirin and/or Atorvastatin	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Subclinical Cardiovascular Disease in Psoriatic Disease
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Psoriatic Disease Patients Moderate to severe psoriatic disease	Drug: Aspirin and/or Atorvastatin; This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
No Intervention: Healthy Control

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Jeffrey Berger, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 22, 2018

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03228017
• Other Study ID Numbers: 17-00692
• First Posted: Jul 24, 2017
• Last Update Posted: Sep 28, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: cardiovascular disease; CVD
• Additional relevant MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Vascular Diseases; Atherosclerosis; Infarction; Aspirin; Atorvastatin

Study Results

Participant Flow

Arm/Group Title	Psoriatic Disease Patients	Healthy Control
Arm/Group Description	Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.	Healthy Control
Period Title: Overall Study
STARTED	45	18
COMPLETED	45	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Psoriatic Disease Patients	Healthy Control	Total
Arm/Group Description	Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.	Healthy Control	Total of all reporting groups
Overall Participants	45	18	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (14.2)	40.5 (12.7)	42.75 (13.5)
Sex: Female, Male (Count of Participants)
Female	23 51.1%	8 44.4%	31 49.2%
Male	22 48.9%	10 55.6%	32 50.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 8.9%	2 11.1%	6 9.5%
Not Hispanic or Latino	38 84.4%	15 83.3%	53 84.1%
Unknown or Not Reported	3 6.7%	1 5.6%	4 6.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 6.7%	2 11.1%	5 7.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 4.4%	3 16.7%	5 7.9%
White	37 82.2%	12 66.7%	49 77.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 6.7%	1 5.6%	4 6.3%
Region of Enrollment (participants) [Number]
United States	45 100%	18 100%	63 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoriatic Disease Patients	Healthy Control
Arm/Group Description	Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.	Healthy Control
Measure Participants	45	18
Mean (Standard Deviation) [Fold Change]	8.6 (8.6)	2.8 (2.2)

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoriatic Disease Patients	Healthy Control
Arm/Group Description	Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.	Healthy Control
Measure Participants	15	15
Mean (Full Range) [Fold Change]	-0.28	-0.04

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoriatic Disease Patients	Healthy Control
Arm/Group Description	Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.	Healthy Control
Measure Participants	20	10
Mean (Full Range) [Fold Change]	-0.1	0.1

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Psoriatic Disease Patients	Healthy Control
Arm/Group Description	Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.	Healthy Control
Measure Participants	15	15
Median (Standard Deviation) [ng/ml]	1 (0.8)	4.05 (3)

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Psoriatic Disease Patients		Healthy Control
Arm/Group Description	Moderate to severe psoriatic disease Aspirin and/or Atorvastatin: This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.		Healthy Control
All Cause Mortality
	Psoriatic Disease Patients		Healthy Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/18 (0%)
Serious Adverse Events
	Psoriatic Disease Patients		Healthy Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Psoriatic Disease Patients		Healthy Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.