Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients (EPRAPAC)

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 Overview

• Status: Recruiting
• Conditions: Anticoagulants and Thrombotic Disorders
• Intervention / Treatment: Other: Monitoring

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Benoit Blanchet, PharmD, PhD; Phone Number: +33 158412889; Email: benoit.blanchet@aphp.fr
• Study Contact Backup: Name: Corinne Frere, MD, PhD; Phone Number: +33 142162458; Email: corinne.frere@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
    • Contact: Joe-Elie SALEM, MD PhD; Phone Number: +33 142178531; Email: joe-elie.salem@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rivaroxaban; Cancer patients treated with rivaroxaban	Other: Monitoring; Monitoring
Apixaban; Cancer patients treated with apixaban	Other: Monitoring; Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Population pharmacokinetic evaluation	Estimated area under the curve (AUC) of each of the 2 drugs studied	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	Any thromboembolic event or major bleeding	3 years

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 2022-10-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No