Apixaban Pharmacokinetics in Bariatric Patients (APB)
Status:
Completed
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of
apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE)
prophylaxis and treatment) in the obese adult population to determine if bariatric surgery
influences apixaban exposure. More interesting would be to see how the dose may need to
change pre- vs. post-bariatric surgery (this will be important for physicians as more and
more patients undergo this procedure worldwide and many may require anticoagulation in their
future healthcare).
Physicians and surgeons are very interested in oral anticoagulants for this special patient
population. To date, there is no approved dosing for the obese patient (especially when
considering surgical intervention such as bariatric surgery).
Primary outcome variable.
To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in
patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two bariatric
surgical procedures (pre-operative versus post-operative vertical sleeve gastrectomy or
Roux-en-Y gastric bypass patients).
Secondary outcome variables.
1. To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric
surgical patients who have undergone RYGB vs. VSG.
2. To determine how the pharmacokinetics of the drug may differ when there is significant
post-operative surgical weight loss (>40% estimated excess body weight) 12 to 18 months
following surgery versus those patients who have suboptimal weight loss following
bariatric surgery (< 40% of estimated excess body weight).