Pharmacokinetics of Rivaroxaban After Bariatric Surgery

NCT ID: NCT04180436

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-06-27

Brief 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 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

morbidly obese patients with BMI ≥ 40

Morbidly obese patients with BMI ≥ 40

Group Type: EXPERIMENTAL

rivaroxaban 20 mg once daily 8 days

Intervention Type: DRUG

Blood samples for the measurement of rivaroxaban PK parameters

Patients operated by gastric bypass

Patients operated by gastric bypass for over a year and with stable weight

Group Type: EXPERIMENTAL

rivaroxaban 20 mg once daily 8 days

Intervention Type: DRUG

Blood samples for the measurement of rivaroxaban PK parameters

Patients operated by sleeve gastrectomy

Patients operated by sleeve gastrectomy for over a year and with stable weight

Group Type: EXPERIMENTAL

rivaroxaban 20 mg once daily 8 days

Intervention Type: DRUG

Blood samples for the measurement of rivaroxaban PK parameters

Control group: non-operated subjects

Control group: non-operated subjects but with an age and a BMI corresponding to those of the patients of the 2 operated groups.

Group Type: EXPERIMENTAL

rivaroxaban 20 mg once daily 8 days

Intervention Type: DRUG

Blood samples for the measurement of rivaroxaban PK parameters

Interventions

rivaroxaban 20 mg once daily 8 days

Blood samples for the measurement of rivaroxaban PK parameters

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de Brest

Brest, France, France

Countries

France

References

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.

Reference Type: RESULT

PMID: 39002729 (View on PubMed)

Other Identifiers

ABSORB (29BRC19.0078)

Identifier Type: -

Identifier Source: org_study_id