Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.

N/ANot Yet RecruitingNCT07151014

Fondazione Policlinico Universitario Agostino Gemelli IRCCS55 enrolled

Overview

The primary objective is to evaluate the cardiovascular profile and the risk of thrombotic events in patients affected by Oral Lichen Planus.

Evaluation of thrombophilia screening parameters, antiphospholipid antibody levels, and platelet aggregability in a cohort of patients affected by Oral Lichen Planus.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Oral Lichen Planus

Interventions

blood sample collectionOTHER

blood sample collection in old patients in order to study the trombophilic risk

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a clinical and histological diagnosis of Oral Lichen Planus * Age \> 18 years * Patients who agree to sign the informed consent form Exclusion Criteria: * Patients under 18 years of age * Patients who do not agree to sign the informed consent form * Patients without a diagnosis of Oral Lichen Planus * Patients with previously known cardiac diseases * History of major cardiovascular events (myocardial infarction, ischemic stroke, TIA) * Patients with overt heart failure (NYHA class III-IV) * Cardiomyopathies not related to the studied risk factors (e.g., genetic hypertrophic cardiomyopathy) * Patients undergoing anticoagulant therapy * Patients with primary or secondary conditions associated with increased cardiovascular risk

Outcomes

Primary Outcomes

Prothrombotic risk evaluation

Primary Outcome Measure 1 Title: Prevalence of Natural Anticoagulant Deficiency * Description: Proportion of patients with Oral Lichen Planus (OLP) showing reduced functional activity of at least one natural anticoagulant (antithrombin III, protein C, or protein S) below the laboratory reference range, measured in plasma samples. * Time Frame: From September 2025 to September 2026 * Unit of Measure: Percentage of participants with abnormal result (%). Primary Outcome Measure 2 Title: Prevalence of Antiphospholipid Antibody Positivity * Description: Proportion of OLP patients with positive antiphospholipid antibodies, defined as anticardiolipin IgG and/or IgM and/or anti-β2-glycoprotein I IgG/IgM above the laboratory cut-off, measured in serum. * Time Frame: From September 2025 to September 2026 * Unit of Measure: Percentage of participants with abnormal result (%).

Time frame: From September 2025 to September 2026

Data from ClinicalTrials.gov

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