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

N/AActive Not RecruitingNCT05750680

Fondazione Policlinico Universitario Agostino Gemelli IRCCS23 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation Thromboembolism, Venous

Interventions

DOACsDRUG

outpatients visited in anticoagulation clinics with a prescription of DOAC for atrial fibrillation and venous thromboembolism and concomitant antiepileptic drug will perform a blood draw for measurement of dabigatran, rivaroxaban, apixaban and edoxaban

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, Roma, Italy

Outcomes

Primary Outcomes

measurement of trough plasma levels of DOACs

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

Time frame: 12 months

Secondary Outcomes

measurement of peak plasma levels of DOACs in patients treated and not treated with EI-EAD

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

Time frame: 12 months

Data from ClinicalTrials.gov

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