Study of a Cohort of Patients Affected by Oral Lichen Planus: Cardiovascular and Prothrombotic Risk in Patients With Oral Lichen Planus.

Not yet recruiting

• Conditions: Oral Lichen Planus

• Registration Number: NCT07151014
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Study Timeline

• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-08-28
• Study First Posted: 2025-09-02
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-01
• Last Update Posted: 2025-10-07
• Study Start: 2025-10-10
• Primary Completion: 2026-09-15
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prothrombotic risk evaluation	From September 2025 to September 2026	Evaluation of thrombophilia screening parameters, antiphospholipid antibody count, and platelet aggregability in a cohort of patients affected by Oral Lichen Planus.; Assessment of prothrombotic risk in patients affected by Oral Lichen Planus (OLP) through separate laboratory measurements: 1. Thrombophilia Screening Parameters - plasma levels of antithrombin III, protein C, and protein S (reported in % activity).; 2. Antiphospholipid Antibodies - anticardiolipin IgG/IgM and anti-β2-glycoprotein I IgG/IgM (reported in GPL/MPL units).; 3. Platelet Aggregability - platelet aggregation percentage measured by light transmission aggregometry (LTA) using ADP and collagen as agonists.; Each parameter will be analyzed and reported as an independent outcome measure with its own unit of measure.