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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Crossover Trial of Antiplatelet Therapies in Psoriasis
- ClinicalTrials.gov ID
- NCT07744191
- Acronym / sponsor ID
- 26-00858
- Conditions
- Psoriasis (PsO), Psoriatic Arthritis (PsA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Aspirin, then Clopidogrel, then Placebo | Experimental | Drug: Aspirin, Drug: Clopidogrel, Other: PlaceboEach 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. |
| Aspirin, then Placebo, then Clopidogrel | Experimental | Drug: Aspirin, Drug: Clopidogrel, Other: PlaceboEach 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. |
| Clopidogrel, then Aspirin, then Placebo | Experimental | Drug: Aspirin, Drug: Clopidogrel, Other: PlaceboEach 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. |
| Clopidogrel, then Placebo, then Aspirin | Experimental | Drug: Aspirin, Drug: Clopidogrel, Other: PlaceboEach 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. |
| Placebo, then Aspirin, then Clopidogrel | Experimental | Drug: Aspirin, Drug: Clopidogrel, Other: PlaceboEach 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. |
| Placebo, then Clopidogrel, then Aspirin | Experimental | Drug: Aspirin, Drug: Clopidogrel, Other: PlaceboEach 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- One of the following:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin81 mg capsule orally once daily for 4 weeks | Drug | Aspirin, then Clopidogrel, then Placebo, Aspirin, then Placebo, then Clopidogrel, Clopidogrel, then Aspirin, then Placebo, Clopidogrel, then Placebo, then Aspirin, Placebo, then Aspirin, then Clopidogrel, Placebo, then Clopidogrel, then Aspirin |
| Clopidogrel75 mg capsule orally once daily for 4 weeks | Drug | Aspirin, then Clopidogrel, then Placebo, Aspirin, then Placebo, then Clopidogrel, Clopidogrel, then Aspirin, then Placebo, Clopidogrel, then Placebo, then Aspirin, Placebo, then Aspirin, then Clopidogrel, Placebo, then Clopidogrel, then Aspirin |
| PlaceboMatching placebo (microcellulose powder) capsule orally once daily for 4 weeks | Other | Aspirin, then Clopidogrel, then Placebo, Aspirin, then Placebo, then Clopidogrel, Clopidogrel, then Aspirin, then Placebo, Clopidogrel, then Placebo, then Aspirin, Placebo, then Aspirin, then Clopidogrel, Placebo, then Clopidogrel, then Aspirin |
Primary outcome
Mean change in the composite endothelial pro-inflammatory transcript expression
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).
Mean change in the composite endothelial pro-inflammatory transcript expression
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).
Mean change in the composite endothelial pro-inflammatory transcript expression
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).
6 secondary outcomes
Change in percent platelet aggregation
Time frame: Baseline, Follow-up Visit 1 (Week 4)
Change in percent platelet aggregation
Time frame: Baseline, Follow-up Visit 3 (Week 12)
Change in percent platelet aggregation
Time frame: Baseline, Final Visit (Week 20)
Change in platelet activation biomarkers
Time frame: Baseline, Follow-up Visit 1 (Week 4)
Change in platelet activation biomarkers
Time frame: Baseline, Follow-up Visit 3 (Week 12)
Change in platelet activation biomarkers
Time frame: Baseline, Final Visit (Week 20)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Boyce contact
Michael Garshick, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Garshick, MD (212-263-8032, Michael.Garshick@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the composite endothelial pro-inflammatory transcript expression (time frame: Baseline, Follow-up Visit 1 (Week 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.