Clinical trial NCT05819736: Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients
Official title: Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulants and Thrombotic Disorders
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with atrial fibrillation or venous thromboembolism receiving rivaroxaban or apixaban in a real-life clinical setting

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Population pharmacokinetic evaluation
timeFrame: 3 years
Secondary outcomes:
measure: Safety evaluation
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Benoit Blanchet, PharmD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Corinne Frere, MD, PhD
role: STUDY_DIRECTOR
References: