Psoriasis (PsO), Psoriatic Arthritis (PsA)
Conditions
Brief summary
The purpose of this study is to determine the effect of antiplatelet therapy on the endovascular phenotype in psoriasis, specifically whether clopidogrel reduces vascular endothelial pro-atherosclerotic transcript expression more than aspirin or placebo. The primary endpoint is mean change in a composite endothelial pro-inflammatory/pro-atherosclerotic transcript expression signature measured from brachial vein endothelial cells.
Interventions
DRUGAspirin
81 mg capsule orally once daily for 4 weeks
DRUGClopidogrel
75 mg capsule orally once daily for 4 weeks
OTHERPlacebo
Matching placebo (microcellulose powder) capsule orally once daily for 4 weeks
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. One of the following: 1. A history of psoriasis as confirmed by a board-certified dermatologist OR 2. A history of psoriatic arthritis as confirmed by a board-certified rheumatologist 2. Age ≥ 18 \& \< 90 years 3. Able and willing to provide written informed consent for the study 4. English-speaking unless a translated informed consent form is approved 5. No previous antiplatelet or anticoagulant use for 14 days prior to enrollment
Exclusion criteria
1. A prior history of a myocardial infarction, stroke/TIA, or occlusive peripheral arterial disease 2. Chronic antiplatelet/anticoagulant use that is not able to be stopped at least 14 days prior to study enrollment 3. Uncontrolled hypertension resting systolic blood pressure \> 180 mm Hg or diabetes HbA1c \> 10% 4. Known active cancer receiving treatment 5. Pregnancy 6. Anemia (hemoglobin \< 9 mg/dl) or thrombocytopenia (Platelet count \<75), or thrombocytosis (Platelet count \>600) 7. A history of severe bleeding or bleeding disorders 8. Active gastrointestinal ulcer 9. Active pathological bleeding. 10. Chronic kidney disease (CrCl \< 30ml/min) 11. Congestive heart failure 12. Known hypersensitivity to or allergy to aspirin, clopidogrel, or any of the components of the study capsules 13. History of aspirin-exacerbated respiratory disease or asthma induced by salicylates or NSAIDs 14. Currently breastfeeding 15. Persons of childbearing potential unwilling to use acceptable contraception during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in the composite endothelial pro-inflammatory transcript expression | Baseline, Follow-up Visit 1 (Week 4) | This endpoint is a validated composite of 9 endothelial-derived pro-atherosclerotic transcripts which I have shown is elevated in psoriasis (CXCL1, IL-8, LTB, IL-1B, CCL3, ICAM1, COX-2, CCL2, CX3CL1), correlated with plaque burden and modifiable. The transcripts are expressed as the log-transformed normalized count values and assessed as (follow-up 4 weeks/baseline time 0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent platelet aggregation | Baseline, Follow-up Visit 1 (Week 4) | Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage. |
| Change in platelet activation biomarkers | Baseline, Follow-up Visit 1 (Week 4) | Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume. |
Countries
United States
Contacts
CONTACTMichael Garshick, MD
CONTACTSarah Boyce
PRINCIPAL_INVESTIGATORMichael Garshick, MD
NYU Langone Health
Outcome results
None listed