JHU ICTR
Johns Hopkins Clinical Research Study

APB study: Apixaban Pharmacokinetics in Bariatric patients
ClinicalTrials.gov

IRB Number: IRB00035495
Principal Investigator: Petty, Brent

Study Description:

This research is being done to see how bariatric surgery and weight loss affect levels of oral anticoagulant (blood thinner). To do this, we will study how the dose of anticoagulant is absorbed prior to surgery. Then we will investigate if the dose should be different from the amount given before surgery. Because the digestive tract is changed with bariatric surgery, it is possible that the absorption of oral anticoagulants is also changed. We will study how the same dose of anticoagulant is absorbed after surgery in comparison to before surgery.  

The oral anticoagulant used in this study is called apixaban (Eliquis™). Apixaban is approved by the Food and Drug Administration (FDA) for the treatment and prevention of blood clots. The dose of apixaban you will receive on each dosing day (5 mg) is the same as the dose given for treatment of blood clots in the legs or the lungs, but more than the dose given to prevent blood clots (2.5 mg).

People who are approved for bariatric surgery at the Johns Hopkins Center for Bariatric Surgery may
join this research study.


Eligibility Criteria:

 Inclusion Criteria:

  • Men or women, 18 to 65 years old with a BMI of 35 kg/m2 or greater who will be undergoing bariatric surgery (VSG and RYGB)
  • Signed written informed consent
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
  • Women must not be breastfeeding

Exclusion Criteria:

  • History of documented clotting/coagulation disorder
  • History of cancer (within the last year)
  • Any diagnosis requiring anti-coagulation
  • History of hypersensitivity reaction to apixaban
  • Active clinically significant bleeding
  • Creatinine > 1.5 mg/dL
  • Participants currently receiving any type of anticoagulation or blood thinning medications, including heparin, low molecular weight heparins, Plavix, aspirin, NSAIDS
  • Participant who is taking any of the excluded medications

    • Combined P-glycoprotein and strong cytochrome P450 (CYP) 3A4 inhibitor
    • Combined P-glycoprotein and moderate CYP 3A4 inhibitor
    • Combined P-glycoprotein inducer and strong CYP 3A4 inducer
    • Inducers of p-glycoprotein
    • Strong inducers of CYP 3A4


Recruitment Contact Name:Robert Juaro, RN
Contact Phone:410-550-8112
Contact E-Mail: rojurao@jhmi.edu


Location of Study Visits:

  • Johns Hopkins Bayview Medical Center

Study will provide compensation: Yes



Keywords:

  • Bariatric Surgery