Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.

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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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

Other

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

Primary outcomes

Prothrombotic risk evaluation

Time frame: 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 (%).

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Prospective Single-center Study of a Cohort of Patients With Oral Lichen Planus: Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus (OLP).

Acronym: LPO_RCP

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Sep 2, 2025
Registry last updated: Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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