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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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
NYU Langone Health
New York, New York, United States
Mean change in the composite endothelial pro-inflammatory transcript expression
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)
Mean change in the composite endothelial pro-inflammatory transcript expression
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)
Mean change in the composite endothelial pro-inflammatory transcript expression
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)
Change in percent platelet aggregation
Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.
Time frame: Baseline, Follow-up Visit 1 (Week 4)
Change in percent platelet aggregation
Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.
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Time frame: Baseline, Follow-up Visit 3 (Week 12)
Change in percent platelet aggregation
Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.
Time frame: Baseline, Final Visit (Week 20)
Change in platelet activation biomarkers
Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.
Time frame: Baseline, Follow-up Visit 1 (Week 4)
Change in platelet activation biomarkers
Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.
Time frame: Baseline, Follow-up Visit 3 (Week 12)
Change in platelet activation biomarkers
Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.
Time frame: Baseline, Final Visit (Week 20)