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Trial Title:
Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients
NCT ID:
NCT05819736
Condition:
Anticoagulants and Thrombotic Disorders
Conditions: Official terms:
Thrombosis
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Monitoring
Description:
Monitoring
Arm group label:
Apixaban
Arm group label:
Rivaroxaban
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
Criteria for eligibility:
Study pop:
Cancer patients with atrial fibrillation or venous thromboembolism receiving rivaroxaban
or apixaban in a real-life clinical setting
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Recruiting
Contact:
Last name:
Joe-Elie SALEM, MD PhD
Phone:
142178531
Phone ext:
+33
Email:
joe-elie.salem@aphp.fr
Start date:
December 1, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Groupe Hospitalier Pitie-Salpetriere
Agency class:
Other
Source:
Groupe Hospitalier Pitie-Salpetriere
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05819736
