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Bariatric Surgery and Pharmacokinetics of Apixaban

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ClinicalTrials.gov Identifier: NCT03448783
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
Volvat Medisinsk Senter Stokkan
Namsos Hospital
Alesund Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date February 22, 2018
First Posted Date February 28, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date January 2, 2018
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2018)
Apixaban concentration in blood serum (area under curve (AUC)) [ Time Frame: From baseline to 1 year postoperatively ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03448783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bariatric Surgery and Pharmacokinetics of Apixaban
Official Title Bariatric Surgery and Pharmacokinetics of Apixaban: BAR-MEDS Apixaban
Brief Summary Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on apixaban.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)
Condition Obesity, Morbid
Intervention Drug: Apixaban
Patients are tested for their normal prescription apixaban medication
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 22, 2018)
12
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
  • Being a Norwegian citizen

Exclusion Criteria:

  • Having previously undergone resections in the GI-tract
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Magnus Strømmen, MSc 0047 72829970 magnus.strommen@stolav.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03448783
Other Study ID Numbers 2016/1145d
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Norwegian University of Science and Technology
Study Sponsor Norwegian University of Science and Technology
Collaborators
  • St. Olavs Hospital
  • Volvat Medisinsk Senter Stokkan
  • Namsos Hospital
  • Alesund Hospital
Investigators
Principal Investigator: Magnus Strømmen, MSc St. Olavs University Hospital
PRS Account Norwegian University of Science and Technology
Verification Date February 2019