Apixaban Pharmacokinetics in Bariatric Patients (APB)

NCT02406885 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00035495
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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. 1.To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric surgical patients who have undergone RYGB vs. VSG.
2. 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).

Conditions

Bariatric Surgery; Obesity

Outcome Measures

Primary Outcomes (3)

• Change in Pharmacokinetics as Assessed by Cmax (Max Concentration)

  To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in Cmax (ng/ml) between 12 months and baseline.

  Baseline and 12 months

• Change in Pharmacokinetics as Assessed by Area Under the Curve (AUC)

  To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in AUC (ng\*h/ml) between 12 months and baseline.

  Baseline to 12 months

• Change in Pharmacokinetics as Assessed by Elimination Half-life

  To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures.

  Baseline and 12 months

Secondary Outcomes (1)

• Change in Pharmacodynamics as Assessed by Factor Xa Levels (Percent Activity)

  Baseline and 12 months

Study Arms (2)

APB study: Apixaban Pharmacokinetics in VSG

ACTIVE COMPARATOR

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

APB study: Apixaban Pharmacokinetics in RYGB

ACTIVE COMPARATOR

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

Interventions

Apixaban DRUG

New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.

Also known as: Eliquis

APB study: Apixaban Pharmacokinetics in RYGB; APB study: Apixaban Pharmacokinetics in VSG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Center for Bariatric Surgery

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Frost C, Wang J, Nepal S, Schuster A, Barrett YC, Mosqueda-Garcia R, Reeves RA, LaCreta F. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol. 2013 Feb;75(2):476-87. doi: 10.1111/j.1365-2125.2012.04369.x.

  PMID: 22759198 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

apixaban

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Brent Petty
• Organization: The Johns Hopkins University School of Medicine

bpg@jhmi.edu

410-955-8181

Study Officials

• Brent Petty

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: April 2, 2015
• Study Start: July 19, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 22, 2020
• Results First Posted: December 22, 2020

Record last verified: 2020-12

Locations

US (1)