Psoriasis (PsO)Phase 4NCT07744191
A Clinical Trial of Antiplatelets in Psoriasis
A Phase 4 study testing Aspirin and Clopidogrel in people with Psoriasis (PsO) and Psoriatic Arthritis (PsA), run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- What is being tested?
- Aspirin and Clopidogrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2031
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One of the following:
- 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
- English-speaking unless a translated informed consent form is approved
- No previous antiplatelet or anticoagulant use for 14 days prior to enrollment
Who cannot join
- 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
- Pregnancy
- Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600)
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- A history of severe bleeding or bleeding disorders
- Active gastrointestinal ulcer
- Active pathological bleeding.
- Chronic kidney disease (CrCl < 30ml/min)
- Congestive heart failure
- Known hypersensitivity to or allergy to aspirin, clopidogrel, or any of the components of the study capsules
- History of aspirin-exacerbated respiratory disease or asthma induced by salicylates or NSAIDs
- Currently breastfeeding
- Persons of childbearing potential unwilling to use acceptable contraception during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Boyce contact
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Crossover Trial of Antiplatelet Therapies in Psoriasis
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.
- Conditions
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- Being tested
- Aspirin, Clopidogrel, Placebo
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
81 mg capsule orally once daily for 4 weeks
ClopidogrelDrug
75 mg capsule orally once daily for 4 weeks
PlaceboOther
Matching placebo (microcellulose powder) capsule orally once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aspirin, then Clopidogrel, then Placebo | Experimental | Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. Receives: Drug: Aspirin; Drug: Clopidogrel; Other: Placebo |
| Aspirin, then Placebo, then Clopidogrel | Experimental | Each subject will take an aspirin 81mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. Receives: Drug: Aspirin; Drug: Clopidogrel; Other: Placebo |
| Clopidogrel, then Aspirin, then Placebo | Experimental | Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. Receives: Drug: Aspirin; Drug: Clopidogrel; Other: Placebo |
| Clopidogrel, then Placebo, then Aspirin | Experimental | Each subject will take will take the clopidogrel 75mg capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the Placebo capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. Receives: Drug: Aspirin; Drug: Clopidogrel; Other: Placebo |
| Placebo, then Aspirin, then Clopidogrel | Experimental | Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. Receives: Drug: Aspirin; Drug: Clopidogrel; Other: Placebo |
| Placebo, then Clopidogrel, then Aspirin | Experimental | Each subject will take will take the Placebo capsule daily for 4 weeks. After a washout period of 4 weeks, they will take the clopidogrel 75mg capsule daily for 4 weeks. After a second washout period of 4 weeks, they will take an aspirin 81mg capsule daily for 4 weeks. Receives: Drug: Aspirin; Drug: Clopidogrel; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Baseline, Final Visit (Week 20)
Secondary outcomes (6)
Change in percent platelet aggregation
Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Final Visit (Week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael Garshick, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744191
- Sponsor's protocol ID
- 26-00858
- Other IDs
- 5K23HL152013
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Michael.Garshick@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.