Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a clinical and histological diagnosis of Oral Lichen Planus

Age > 18 years

Patients who agree to sign the informed consent form

Disqualifiers

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

Trial population

Patients affected by oral lichen planus

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • blood sample collection

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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