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Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

NCT05819736 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-04-24

No results posted yet for this study

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.

Conditions

  • Anticoagulants and Thrombotic Disorders

Interventions

OTHER

Monitoring

Monitoring

Sponsors & Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

    lead OTHER

Principal Investigators

  • Benoit Blanchet, PharmD, PhD · Assistance Publique - Hôpitaux de Paris

  • Corinne Frere, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819736 on ClinicalTrials.gov