A Randomized Clinical Trial of Antiplatelets in Psoriasis

NCT07744191 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: 26-008585K23HL152013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (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).

  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).

  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).

  Baseline, Final Visit (Week 20)

Secondary Outcomes (6)

• Change in percent platelet aggregation

  Baseline, Follow-up Visit 1 (Week 4)

• Change in percent platelet aggregation

  Baseline, Follow-up Visit 3 (Week 12)

• Change in percent platelet aggregation

  Baseline, Final Visit (Week 20)

• Change in platelet activation biomarkers

  Baseline, Follow-up Visit 1 (Week 4)

• Change in platelet activation biomarkers

  Baseline, Follow-up Visit 3 (Week 12)

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: Aspirin; Drug: Clopidogrel; Other: Placebo

Interventions

Aspirin DRUG

81 mg capsule orally once daily for 4 weeks

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

Clopidogrel DRUG

75 mg capsule orally once daily for 4 weeks

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

Placebo OTHER

Matching placebo (microcellulose powder) capsule orally once daily for 4 weeks

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael Garshick, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Garshick, MD

CONTACT

212-263-8032; Michael.Garshick@nyulangone.org

Sarah Boyce

CONTACT

Sarah.Boyce@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Michael.Garshick@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)