Pharmacokinetics of Rivaroxaban After Bariatric Surgery
Status:
Recruiting
Trial end date:
2021-12-29
Target enrollment:
Participant gender:
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.