A Clinical Trial of Antiplatelets in Psoriasis | NCT07744191

NCT07744191

Overview

NCT ID: NCT07744191
Lead Sponsor: NYU Langone HealthOTHER
Official Title: A Randomized, Double-blind, Placebo-controlled Crossover Trial of Antiplatelet Therapies in Psoriasis
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)
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Sep 2031Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking

Contacts and Locations

Central Contacts: Michael Garshick, MDContact
Michael.Garshick@nyulangone.org

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