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Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients
Sponsor: Groupe Hospitalier Pitie-Salpetriere
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
193
Start Date
2022-12-01
Completion Date
2026-05-18
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
Monitoring
Monitoring
Locations (1)
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
Paris, France