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OpenTrials
Active, Not Recruiting

NCT Number: NCT05750680

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Thromboembolism, Venous Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DOACs

Drug

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

Primary outcomes

  1. measurement of trough plasma levels of DOACs

    Time frame: 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 outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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