A Clinical Trial of Antiplatelets in Psoriasis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A history of psoriasis as confirmed by a board-certified dermatologist OR
A history of psoriatic arthritis as confirmed by a board-certified rheumatologist
Age ≥ 18 & < 90 years
Able and willing to provide written informed consent for the study
Disqualifiers
A prior history of a myocardial infarction, stroke/TIA, or occlusive peripheral arterial disease
Chronic antiplatelet/anticoagulant use that is not able to be stopped at least 14 days prior to study enrollment
Uncontrolled hypertension resting systolic blood pressure > 180 mm Hg or diabetes HbA1c > 10%
Known active cancer receiving treatment
Trial design
Design model
Crossover
Treatments tested in this trial
Aspirin
Drug81 mg capsule orally once daily for 4 weeks
Clopidogrel
Drug75 mg capsule orally once daily for 4 weeks
Placebo
Other interventionMatching placebo (microcellulose powder) capsule orally once daily for 4 weeks
Treatment groups
60 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Aspirin, then Clopidogrel, then PlaceboExperimental treatment 3 interventions
Group B: Aspirin, then Placebo, then ClopidogrelExperimental treatment 3 interventions
Group C: Clopidogrel, then Aspirin, then PlaceboExperimental treatment 3 interventions
Group D: Clopidogrel, then Placebo, then AspirinExperimental treatment 3 interventions
Group E: Placebo, then Aspirin, then ClopidogrelExperimental treatment 3 interventions
Group F: Placebo, then Clopidogrel, then AspirinExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)Secondary outcomes
1
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)2
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 3 (Week 12)3
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)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 1 (Week 4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: