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COMPLETED
NCT05819736

Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

Sponsor: Groupe Hospitalier Pitie-Salpetriere

View on ClinicalTrials.gov

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

Interventions

OTHER

Monitoring

Monitoring

Locations (1)

Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière

Paris, France