EPRAPAC: Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients
Study Details
Study Description
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 :
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to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rivaroxaban Cancer patients treated with rivaroxaban |
Other: Monitoring
Monitoring
|
| Apixaban Cancer patients treated with apixaban |
Other: Monitoring
Monitoring
|
Outcome Measures
Primary Outcome Measures
- Population pharmacokinetic evaluation [3 years]
Estimated area under the curve (AUC) of each of the 2 drugs studied
Secondary Outcome Measures
- Safety evaluation [3 years]
Any thromboembolic event or major bleeding
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects with age ≥ 18 years
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Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 6 months prior to inclusion
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Confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation
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Patients affiliated with a health insurance system
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Able to provide written informed consent.
Exclusion Criteria:
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Age <18 years
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Pregnancy or breastfeeding
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Patients not affiliated with a health insurance system
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Patient subject to a measure of protection
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Legally protected adults
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Life expectancy < 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière | Paris | France | 75013 |
Sponsors and Collaborators
- Groupe Hospitalier Pitie-Salpetriere
Investigators
- Study Director: Benoit Blanchet, PharmD, PhD, Assistance Publique - Hôpitaux de Paris
- Study Director: Corinne Frere, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-10-15