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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Thromboembolism, Venous

Treatments: Drug: DOACs

Study type: Observational

Funder types: Other

Identifiers

NCT05750680

3981

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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