Bariatric SurgeryPhase 1ABSORBNCT04180436
Pharmacokinetics of Rivaroxaban After Bariatric Surgery
A Phase 1 study testing rivaroxaban 20 mg once daily 8 days in people with Bariatric Surgery and Morbid Obesity, run by University Hospital, Brest at 1 site in France.
Trial summary
Data on pharmacokinetics of rivaroxaban after bariatric surgery and in morbid obesity are sparse. The aim of this study is to assess the pharmacokinetic and pharmacodynamic parameters of rivaroxaban, used at a therapeutic anticoagulant dose, in patients with previous bariatric surgery, with sleeve gastrectomy or… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Morbid Obesity
- What is being tested?
- rivaroxaban 20 mg once daily 8 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2020to 27 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Creatinine clearance measured by the Cockroft formula ≥ 60 mL / min
- Patient meeting the specific criteria of one of the 4 groups:
- morbidly obese patients with BMI ≥ 40
- Patients operated by gastric bypass for over a year and with stable weight
- Patients operated by sleeve gastrectomy for over a year and with stable weight
- Control group: non-operated subjects but with an age and a BMI corresponding to those of the patients of the 2 operated groups.
Who cannot join
- Indication for anticoagulant therapy, antiplatelet therapy or long-term nonsteroidal anti-inflammatory drugs
- Clinically significant bleeding in progress
- Taking oral or parenteral anticoagulants, or taking platelet antiaggregants within 4 weeks before inclusion
- Congenital or acquired hemorrhagic disorders (eg von Willebrand disease, hemophilia)
- Injury or disease, at significant risk of major bleeding (gastrointestinal ulceration, presence of malignant tumors with a high risk of bleeding, recent brain or spinal cord injury, recent cerebral, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected oesophageal varices , arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities)
- Severe uncontrolled arterial hypertension
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- Active gastrointestinal disease potentially leading to bleeding disorders (esophagitis, gastritis, gastroesophageal reflux disease, chronic inflammatory bowel disease)
- Vascular retinopathy
- Bronchiectasis or history of pulmonary bleeding
- Hypersensitivity to the active substance or to any of the excipients of rivaroxaban
- Hepatic involvement associated with coagulopathy and clinically significant bleeding risk, including cirrhotic patients with Child Pugh Grade B or C score
- Concomitant use of potent inhibitors or inducers of CYP3A4 and / or P-gp (azole antifungal or HIV protease inhibitor)
- Participation in a paid and / or therapeutic study in the previous 3 months
- Pregnant or lactating women,
- Women of childbearing potential not using effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Pharmacodynamics of rivAroxaban After Bariatric Surgery and in mORBid Obesity
Data on pharmacokinetics of rivaroxaban after bariatric surgery and in morbid obesity are sparse. The aim of this study is to assess the pharmacokinetic and pharmacodynamic parameters of rivaroxaban, used at a therapeutic anticoagulant dose, in patients with previous bariatric surgery, with sleeve gastrectomy or gastric bypass, and in morbid obese subjects.
Four groups of 16 subjects per group are studied: Morbid obese subjects / Subjects who have undergone gastric bypass surgery / Subjects who have undergone sleeve gastrectomy surgery / Non-operated control subjects matched for age and BMI with operated subjects.
All patients (obese, surgical patients, and controls) will receive rivaroxaban 20mg once daily during 8 days. Blood samples will be taken predose (Baseline) and 0.5, 1, 2, 3, 6, 9, 12 and 24h post rivaroxaban administration at day1 and day8. PK and PD parameters will be compared between groups in order to explore the impact of bariatric surgery, type of surgery and body mass index on the pharmacological profile of rivaroxaban.
- Conditions
- Bariatric Surgery, Morbid Obesity
- Being tested
- rivaroxaban 20 mg once daily 8 days
- Keywords
- sleeve gastrectomy, gastric bypass, morbid obesity
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxaban 20 mg once daily 8 daysDrug
Blood samples for the measurement of rivaroxaban PK parameters
| Study group | Role | What they receive |
|---|---|---|
| morbidly obese patients with BMI ≥ 40 | Experimental | Morbidly obese patients with BMI ≥ 40 Receives: Drug: rivaroxaban 20 mg once daily 8 days |
| Patients operated by gastric bypass | Experimental | Patients operated by gastric bypass for over a year and with stable weight Receives: Drug: rivaroxaban 20 mg once daily 8 days |
| Patients operated by sleeve gastrectomy | Experimental | Patients operated by sleeve gastrectomy for over a year and with stable weight Receives: Drug: rivaroxaban 20 mg once daily 8 days |
| Control group: non-operated subjects | Experimental | Control group: non-operated subjects but with an age and a BMI corresponding to those of the patients of the 2 operated groups. Receives: Drug: rivaroxaban 20 mg once daily 8 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of rivaroxaban
Rivaroxaban plasma concentrations was assessed by the reference method at the different sampling points to determine the area under the curve (AUC)
Measured: up to 8 days
Cmax of rivaroxaban
Cmax of rivaroxaban was assessed
Measured: up to 8 days
Tmax of rivaroxaban
Tmax of rivaroxaban was assessed
Measured: up to 8 days
Secondary outcomes (8)
Prothrombin time
Prothrombin time of rivaroxaban was assessed
Measured: up to 8 days
Activated partial thromboplatin time (aPTT)
Activated partial thromboplatin time was assessed
Measured: up to 8 days
Fibrinogen levels
Fibrinogen levels was was assessed
Measured: up to 8 days
Rivaroxaban anti-Xa activity
Rivaroxaban anti-Xa activity was assessed
Measured: up to 8 days
Rate of bleedings
Treatment-Related Adverse Events were assessed
Measured: up to 15 days
Other adverse events
Number of other adverse events than bleedings was assessed
Measured: up to 15 days
Thrombin generation test of rivaroxaban
Thrombogram (thrombin generation test) data for each time analyzed allows measurement of peak height . These data will be used to model the PD of rivaroxaban and to estimate the PD variability.
Measured: up to 8 days
Thrombin generation test of rivaroxaban
Thrombogram (thrombin generation test) data for each time analyzed allows measurement of thrombin generation potential (FTE). These data will be used to model the PD of rivaroxaban and to estimate the PD variability.
Measured: up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start15 Jan 2020
- Primary completion21 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180436
- Sponsor's protocol ID
- ABSORB (29BRC19.0078)
- Acronym
- ABSORB
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Leven C, Delavenne X, Roche C, Bressollette L, Couturaud F, Lacut K, Thereaux J. Full-dose rivaroxaban in patients with a history of bariatric surgery: bridging the knowledge gap through a phase 1 study. J Thromb Haemost. 2024 Oct;22(10):2844-2854. doi: 10.1016/j.jtha.2024.06.024. Epub 2024 Jul 11.
PubMed 39002729
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of rivAroxaban After Bariatric Surgery and in mORBid Obesity
- ClinicalTrials.gov ID
- NCT04180436
- Acronym / sponsor ID
- ABSORB / ABSORB (29BRC19.0078)
- Conditions
- Bariatric Surgery, Morbid Obesity
- Keywords
- sleeve gastrectomy, gastric bypass, morbid obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data on pharmacokinetics of rivaroxaban after bariatric surgery and in morbid obesity are sparse. The aim of this study is to assess the pharmacokinetic and pharmacodynamic parameters of rivaroxaban, used at a therapeutic anticoagulant dose, in patients with previous bariatric surgery, with sleeve gastrectomy or gastric bypass, and in morbid obese subjects.
Four groups of 16 subjects per group are studied: Morbid obese subjects / Subjects who have undergone gastric bypass surgery / Subjects who have undergone sleeve gastrectomy surgery / Non-operated control subjects matched for age and BMI with operated subjects.
All patients (obese, surgical patients, and controls) will receive rivaroxaban 20mg once daily during 8 days. Blood samples will be taken predose (Baseline) and 0.5, 1, 2, 3, 6, 9, 12 and 24h post rivaroxaban administration at day1 and day8. PK and PD parameters will be compared between groups in order to explore the impact of bariatric surgery, type of surgery and body mass index on the pharmacological profile of rivaroxaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| morbidly obese patients with BMI ≥ 40 | Experimental | Drug: rivaroxaban 20 mg once daily 8 daysMorbidly obese patients with BMI ≥ 40 |
| Patients operated by gastric bypass | Experimental | Drug: rivaroxaban 20 mg once daily 8 daysPatients operated by gastric bypass for over a year and with stable weight |
| Patients operated by sleeve gastrectomy | Experimental | Drug: rivaroxaban 20 mg once daily 8 daysPatients operated by sleeve gastrectomy for over a year and with stable weight |
| Control group: non-operated subjects | Experimental | Drug: rivaroxaban 20 mg once daily 8 daysControl group: non-operated subjects but with an age and a BMI corresponding to those of the patients of the 2 operated groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Creatinine clearance measured by the Cockroft formula ≥ 60 mL / min
- Patient meeting the specific criteria of one of the 4 groups:
- morbidly obese patients with BMI ≥ 40
- Patients operated by gastric bypass for over a year and with stable weight
- Patients operated by sleeve gastrectomy for over a year and with stable weight
Key exclusion criteria (15 listed)
- Indication for anticoagulant therapy, antiplatelet therapy or long-term nonsteroidal anti-inflammatory drugs
- Clinically significant bleeding in progress
- Taking oral or parenteral anticoagulants, or taking platelet antiaggregants within 4 weeks before inclusion
- Congenital or acquired hemorrhagic disorders (eg von Willebrand disease, hemophilia)
- Injury or disease, at significant risk of major bleeding (gastrointestinal ulceration, presence of malignant tumors with a high risk of bleeding, recent brain or spinal cord injury, recent cerebral, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected oesophageal varices , arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rivaroxaban 20 mg once daily 8 daysBlood samples for the measurement of rivaroxaban PK parameters | Drug | Control group: non-operated subjects, Patients operated by gastric bypass, Patients operated by sleeve gastrectomy, morbidly obese patients with BMI ≥ 40 |
Primary outcome
AUC of rivaroxaban
Time frame: up to 8 days
Rivaroxaban plasma concentrations was assessed by the reference method at the different sampling points to determine the area under the curve (AUC)
Cmax of rivaroxaban
Time frame: up to 8 days
Cmax of rivaroxaban was assessed
Tmax of rivaroxaban
Time frame: up to 8 days
Tmax of rivaroxaban was assessed
8 secondary outcomes
Prothrombin time
Time frame: up to 8 days
Activated partial thromboplatin time (aPTT)
Time frame: up to 8 days
Fibrinogen levels
Time frame: up to 8 days
Rivaroxaban anti-Xa activity
Time frame: up to 8 days
Rate of bleedings
Time frame: up to 15 days
Other adverse events
Time frame: up to 15 days
Thrombin generation test of rivaroxaban
Time frame: up to 8 days
Thrombin generation test of rivaroxaban
Time frame: up to 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 39002729Leven C, Delavenne X, Roche C, Bressollette L, Couturaud F, Lacut K, Thereaux J. Full-dose rivaroxaban in patients with a history of bariatric surgery: bridging the knowledge gap through a phase 1 study. J Thromb Haemost. 2024 Oct;22(10):2844-2854. doi: 10.1016/j.jtha.2024.06.024. Epub 2024 Jul 11.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rivaroxaban 20 mg once daily 8 days in people with Bariatric Surgery and Morbid Obesity, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of rivaroxaban (time frame: up to 8 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04180436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.