Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.

NCT07151014 — Not yet recruiting, 55 participants, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Prospective Single-center Study of a Cohort of Patients With Oral Lichen Planus: Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus (OLP).

RegistryNCT07151014, acronym LPO_RCP
StatusNot yet recruiting
Study typeObservational
Enrollment55 (Estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
ConditionsOral Lichen Planus
Interventionsblood sample collection (Other)
Datesstart 2026-01-01 (estimated), primary completion 2026-09-15 (estimated), completion 2027-02-15 (estimated), first posted 2025-09-02, last updated 2026-01-12

Related Papers Related Patents Related Grants Related Experts
All trials for Oral Lichen Planus All trials of blood sample collection

-Summary

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

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+Detailed description

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

+Arms and interventions

  • blood sample collection (Other): blood sample collection in old patients in order to study the trombophilic risk

+Outcome measures

Primary outcomes

  • Prothrombotic risk evaluation [From September 2025 to September 2026]: 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 (%).

+Eligibility

Sex: All, ages: 18 Years to any

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

+Study documents