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

NCT05750680 | Active Not Recruiting DMC

• 1 other identifier: 3981
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atrial Fibrillation; Thromboembolism, Venous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For sample size calculation we used data from a pilot study on 10 patients and controls. A significant difference of subject frequency with DOAC plasma concentrations below the expected peak value, respectively 35% and 10% for patients using or not using EI/AED, was defined as the primary end-point. A sample size of 40 subjects in each group was estimated for 80% power and alfa = 0.05

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Erica De Candia, MD

  Fondazione Policlinico Universitario A.Gemelli IRCCS Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.ssa Erica De Candia

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: May 13, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-09

Locations

IT (1)