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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Blood samples for the measurement of rivaroxaban PK parameters
CHRU de Brest
Brest, France, France
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)
Time frame: up to 8 days
Cmax of rivaroxaban
Cmax of rivaroxaban was assessed
Time frame: up to 8 days
Tmax of rivaroxaban
Tmax of rivaroxaban was assessed
Time frame: up to 8 days
Prothrombin time
Prothrombin time of rivaroxaban was assessed
Time frame: up to 8 days
Activated partial thromboplatin time (aPTT)
Activated partial thromboplatin time was assessed
Time frame: up to 8 days
Fibrinogen levels
Fibrinogen levels was was assessed
Time frame: up to 8 days
Rivaroxaban anti-Xa activity
Rivaroxaban anti-Xa activity was assessed
Time frame: up to 8 days
Rate of bleedings
Treatment-Related Adverse Events were assessed
Time frame: up to 15 days
Other adverse events
Number of other adverse events than bleedings was assessed
Time frame: 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.
Time frame: 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.
Time frame: up to 8 days
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