NCT05750680

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

Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 23 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Thromboembolism, Venous

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-13
• Primary completion: 2023-04-01
• Completion: 2025-05-01
• First posted: 2023-03-02
• Last updated: 2025-02-27

Locations

1 site across 1 country: Italy