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CompletedNCT05819736EPRAPACUpdated Jun 2, 2026

Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

An observational study in Anticoagulants and Thrombotic Disorders, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
193
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Anticoagulants and Thrombotic Disorders
03

In context

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 66 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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
  • \< 3 months
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
193 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Rivaroxaban

    Cancer patients treated with rivaroxaban

    Other: Monitoring

  • Apixaban

    Cancer patients treated with apixaban

    Other: Monitoring

Interventions

  • OtherMonitoring

    Monitoring

06

What researchers measure

Primary outcomes

  1. Population pharmacokinetic evaluation

    Estimated area under the curve (AUC) of each of the 2 drugs studied

    Time frame: 3 years

Secondary outcomes

  1. Safety evaluation

    Any thromboembolic event or major bleeding

    Time frame: 3 years

07

Study locations

1 site
  • Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
    Paris, 75013, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05819736
Lead sponsor
Groupe Hospitalier Pitie-Salpetriere
Responsible party
Joe Elie Salem (Clinical Professor, Clinical Investigation Center Paris Est, Groupe Hospitalier Pitie-Salpetriere) — Principal investigator
First posted
Apr 19, 2023
Start date
Dec 1, 2022
Primary completion
May 18, 2026
Completion
May 18, 2026
Last update
Jun 2, 2026

Study contacts

Benoit Blanchet, PharmD, PhD
study director · Assistance Publique - Hôpitaux de Paris
Corinne Frere, MD, PhD
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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