NYU Langone Health
New York, 10016, United States
NCT Number: NCT07744191
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Interventional
Phase 4
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
81 mg capsule orally once daily for 4 weeks
75 mg capsule orally once daily for 4 weeks
Matching placebo (microcellulose powder) capsule orally once daily for 4 weeks
Time frame: 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).
Time frame: Baseline, Follow-up Visit 3 (Week 12)
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).
Time frame: Baseline, Final Visit (Week 20)
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).
Time frame: Baseline, Follow-up Visit 1 (Week 4)
Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.
Time frame: Baseline, Follow-up Visit 3 (Week 12)
Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.
Time frame: Baseline, Final Visit (Week 20)
Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.
Time frame: Baseline, Follow-up Visit 1 (Week 4)
Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.
Time frame: Baseline, Follow-up Visit 3 (Week 12)
Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.
Time frame: Baseline, Final Visit (Week 20)
Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.
Contact information is provided by the study sponsor or research team.
NYU Langone Health
Other
A Randomized, Double-blind, Placebo-controlled Crossover Trial of Antiplatelet Therapies in Psoriasis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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