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Trial record 1 of 2 for:    anticoagulation | bariatric surgery
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Apixaban Pharmacokinetics in Bariatric Patients (APB) (APB)

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ClinicalTrials.gov Identifier: NCT02406885
Recruitment Status : Recruiting
First Posted : April 2, 2015
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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).

Condition or disease Intervention/treatment Phase
Bariatric Surgery Obesity Drug: Apixaban Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: APB Study: Apixaban Pharmacokinetics in Bariatric Patients
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Active Comparator: APB study: Apixaban Pharmacokinetics in VSG
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 pre vs. post surgery for patients undergoing vertical sleeve gastrectomy
Drug: Apixaban
New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
Other Name: Eliquis

Active Comparator: APB study: Apixaban Pharmacokinetics in RYGB
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 pre vs. post surgery for patients undergoing Roux-en Y gastric bypass.
Drug: Apixaban
New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
Other Name: Eliquis




Primary Outcome Measures :
  1. Change in pharmacokinetics as assessed by Cmax (max concentration) [ Time Frame: 18 months ]
    To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures

  2. Change in pharmacokinetics as assesed by AUC [ Time Frame: 18 months ]
    To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures

  3. Change in pharmacokinetics as assesed by elimination half-life [ Time Frame: 18 months ]
    To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures


Secondary Outcome Measures :
  1. Change in pharmacodynamics as assessed by Factor Xa levels [ Time Frame: 18 months ]
    To determine the durability or change in pharmacodynamics of apixaban in patients with obesity following one of two bariatric surgical procedures



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406885


Contacts
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Contact: Kimberley E Steele, MD, Ph.D., FACS 410-550-0409 ksteele3@jhmi.edu
Contact: Civonnia Harris 202-670-8599 charr113@jhmi.edu

Locations
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United States, Maryland
The Johns Hopkins Center for Bariatric Surgery Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kimberely E Steele, MD, PhD    410-550-0409      
Contact: Civonnia Harris    202-670-8599    charr113@jhmi.edu   
Principal Investigator: Kimberley E Steele, MD, PhD         
Principal Investigator: Grant G Petty, MD         
Sub-Investigator: Michael A Schweitzer, MD         
Sub-Investigator: Thomas H Magnuson, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Brent Petty Johns Hopkins University
Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02406885    
Other Study ID Numbers: IRB00035495
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants