Phase 4
N=63
Subclinical Cardiovascular Disease in Psoriatic Disease
Cardiovascular Diseases · Myocardial Infarction · Atherosclerotic Cardiovascular Disease · Thrombotic Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT03228017 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript — 8.6; 2.8 Fold Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aspirin and/or Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript |
8.6; 2.8 | — |
| SECONDARY Fold Change Change in Composite Endothelial Inflammation |
-0.28; -0.04 | — |
| SECONDARY Fold Change in Composite Endothelial Inflammation |
-0.1; 0.1 | — |
| SECONDARY Change in Levels of Circulating Thromboxane B2 |
1; 4.05 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT03228017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.