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Not yet recruiting NCT07744191

A Clinical Trial of Antiplatelets in Psoriasis

Phase IV Interventional Psoriasis (PsO) Psoriatic Arthritis (PsA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, Clopidogrel, Placebo.
Who it may be relevant to
Registry conditions: Psoriasis (PsO), Psoriatic Arthritis (PsA). Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Aspirin
    81 mg capsule orally once daily for 4 weeks
  • Drug Clopidogrel
    75 mg capsule orally once daily for 4 weeks
  • Other Placebo
    Matching placebo (microcellulose powder) capsule orally once daily for 4 weeks

Primary outcome measures

  • Mean change in the composite endothelial pro-inflammatory transcript expression [Time frame: Baseline, Follow-up Visit 1 (Week 4)]
  • Mean change in the composite endothelial pro-inflammatory transcript expression [Time frame: Baseline, Follow-up Visit 3 (Week 12)]
  • Mean change in the composite endothelial pro-inflammatory transcript expression [Time frame: Baseline, Final Visit (Week 20)]
Secondary outcome measures (6)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07744191 · 26-00858 · 5K23HL152013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗