DOCE Study Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers

Active, not recruiting

• Conditions: Thromboembolism, Venous; Atrial Fibrillation

• Registration Number: NCT05750680
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism

Detailed Description

Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism. Also the difference between DOACs inducing both CYP3A4 and P-gp transporter (rivaroxaban and apixaban) and DOACs inducing the P-pg transporter only will be investigated. Thriomboembolic and bleeding events during the study duration will be registered and correlated to the measured DOAC plasma levels.

Study Timeline

• Study Start: 2021-05-13
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Primary Completion: 2023-04-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• patients with a diagnosis of nonvalvular atrial fibrillation or a diagnosis of venous thromboembolism who are taking direct oral anticoagulants according to current guidelines and concomitant enzyme inducers antiepileptic drugs; patients available for a 12 months follow up; patients who can sign informed consent

Exclusion Criteria

• patients who stop antiepileptic drugs; age <18 yo patients not willing to perform blood draw or not available for a 12 months follow up; patients who cannot sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measurement of trough plasma levels of DOACs	12 months	measurement of trough plasma levels of DOACs in patients with NVAF and VTE under concomitant therapy with enzyme inducer antiepileptic drugs (EI-AED) and comparison with NVAF and VTE DOAC- treated patients with no EI-AED concomitant therapy

Secondary Outcome Measures

Name	Time	Method
measurement of peak plasma levels of DOACs in patients treated and not treated with EI-EAD	12 months	measurement of peak plasma levels of DOACs in patients treated and not treated with EI-EAD and registration of clinical outcomes of thromboembolic and bleeding events during the study duration

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS; 🇮🇹 Roma, Italy