Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients (EPRAPAC)

Groupe Hospitalier Pitie-Salpetriere

Status: Enrolling

Conditions: Anticoagulants and Thrombotic Disorders

Treatments: Other: Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT05819736

2022-10-15

Details and patient eligibility

About

Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims :

• to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
• to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting.

Full description

Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims :

• to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
• to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects with age ≥ 18 years
• Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 6 months prior to inclusion
• Confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation
• Patients affiliated with a health insurance system
• Able to provide written informed consent.

Exclusion criteria

• Age <18 years
• Pregnancy or breastfeeding
• Patients not affiliated with a health insurance system
• Patient subject to a measure of protection
• Legally protected adults
• Life expectancy < 3 months

Trial design

400 participants in 2 patient groups

Rivaroxaban

Description:

Cancer patients treated with rivaroxaban

Treatment:

Other: Monitoring

Apixaban

Description:

Cancer patients treated with apixaban

Treatment:

Other: Monitoring