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

Atrial Fibrillation Clinical Trial

Official title:

Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750680
• Other study ID #: 3981
• Status: Recruiting
• Start date: May 13, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Erica De Candia, MD
• Phone: 0630156329
• Email: erica.decandia[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thromboembolism
• Thromboembolism, Venous
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A.Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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