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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers

Conditions
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Atrial Fibrillation, Thromboembolism, Venous

Intervention / Treatment
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* Drug: DOACs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DOACs|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months |