Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07744191

A Clinical Trial of Antiplatelets 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Aspirin

Drug

81 mg capsule orally once daily for 4 weeks

clopidogrel

Drug

75 mg capsule orally once daily for 4 weeks

Placebo

Other

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. Change in percent platelet aggregation

    Time frame: Baseline, Follow-up Visit 1 (Week 4)

    Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.

  2. Change in percent platelet aggregation

    Time frame: Baseline, Follow-up Visit 3 (Week 12)

    Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.

  3. Change in percent platelet aggregation

    Time frame: Baseline, Final Visit (Week 20)

    Change from baseline in platelet aggregation measured by light transmission aggregometry, reported as a percentage.

  4. Change in platelet activation biomarkers

    Time frame: Baseline, Follow-up Visit 1 (Week 4)

    Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.

  5. Change in platelet activation biomarkers

    Time frame: Baseline, Follow-up Visit 3 (Week 12)

    Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.

  6. Change in platelet activation biomarkers

    Time frame: Baseline, Final Visit (Week 20)

    Within-participant change from baseline in soluble platelet activation biomarkers. Measured in mass-per-volume.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Garshick, MD

CONTACT

[email protected]

212-263-8032

Sarah Boyce

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Crossover Trial of Antiplatelet Therapies in Psoriasis

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 4, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.