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Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07151014
Acronym
LPO_RCP
Enrollment
55
Registered
2025-09-02
Start date
2026-01-31
Completion date
2027-02-15
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

oral lichen planus, Prothrombotic risk, trombophilia screening

Brief summary

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

Detailed description

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

Interventions

OTHERblood sample collection

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Prothrombotic risk evaluationFrom September 2025 to September 2026Primary 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 (%).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026