Anticoagulants and Thrombotic Disorders
Conditions
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
Interventions
OTHERMonitoring
Monitoring
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Population pharmacokinetic evaluation | 3 years | Estimated area under the curve (AUC) of each of the 2 drugs studied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation | 3 years | Any thromboembolic event or major bleeding |
Countries
France
Contacts
STUDY_DIRECTORBenoit Blanchet, PharmD, PhD
Assistance Publique - Hôpitaux de Paris
STUDY_DIRECTORCorinne Frere, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed