Pharmacokinetics of Rivaroxaban After Bariatric Surgery

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.

Timeline

Start

2020-01-15

Primary completion

2022-06-21

Completion

2022-06-27

Publications

• Results 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.

Drugs

Indications