Trial Outcomes & Findings for Subclinical Cardiovascular Disease in Psoriatic Disease (NCT NCT03228017)

NCT ID: NCT03228017

Last Updated: 2021-09-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 63 participants
• Primary outcome timeframe: Baseline, 5 Months
• Results posted on: 2021-09-28

Participant Flow

Participant milestones

Measure	Psoriatic Disease Patients 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 Healthy Control
Overall Study STARTED	45	18
Overall Study COMPLETED	45	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subclinical Cardiovascular Disease in Psoriatic Disease

Baseline characteristics by cohort

Measure	Psoriatic Disease Patients n=45 Participants 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 n=18 Participants Healthy Control	Total n=63 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 14.2 • n=5 Participants	40.5 years STANDARD_DEVIATION 12.7 • n=7 Participants	42.75 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	8 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	15 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	12 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	18 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 5 Months

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

Outcome measures

Measure	Psoriatic Disease Patients n=45 Participants 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 n=18 Participants Healthy Control
Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript	8.6 Fold Change Standard Deviation 8.6	2.8 Fold Change Standard Deviation 2.2

SECONDARY outcome

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

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

Outcome measures

Measure	Psoriatic Disease Patients n=15 Participants 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 n=15 Participants Healthy Control
Fold Change Change in Composite Endothelial Inflammation	-0.28 Fold Change Interval -0.4 to -0.15	-0.04 Fold Change Interval -0.17 to 0.09

SECONDARY outcome

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

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

Outcome measures

Measure	Psoriatic Disease Patients n=20 Participants 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 n=10 Participants Healthy Control
Fold Change in Composite Endothelial Inflammation	-0.1 Fold Change Interval -0.21 to -0.003	0.1 Fold Change Interval -0.04 to 0.25

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Psoriatic Disease Patients n=15 Participants 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 n=15 Participants Healthy Control
Change in Levels of Circulating Thromboxane B2	1 ng/ml Standard Deviation 0.8	4.05 ng/ml Standard Deviation 3

Adverse Events

Psoriatic Disease Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Garshick

NYU Langone

Phone: 212-263-0855

Email: michael.garshick@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place