NCT02438098

Brief Summary

Until now there ist no systematic investigation of the pharmacokinetic parameters of Rivaroxaban in obese patient undergoing bariatric surgery. The aim of this study is to investigate the pharmacokinetic and pharmacodynamic parameters of rivaroxaban in obese patients before and after bariatric surgery. Patients receive the day before the surgical intervention the first dose of Rivaroxaban (10mg). During the following 24 hours, 9 blood samples are taken. The second tablet Rivaroxaban is administered on the third postoperative day, followed again by 9 blood samples during the next 24 hours. All other blood samples are taken independent from this clinical trial as part of the standard medical treatment during the hospitalization. The hospital stay will not be extended by the study. The outpatient regular follow-up takes place one month after surgery and is combined with the last study visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

April 28, 2015

Last Update Submit

January 7, 2016

Conditions

Prophylaxis of Venous Thromboembolism

Keywords

RivaroxabanObesityBariatric surgeryPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Geometric mean ratio of rivaroxaban AUC (after surgery / before surgery)

    1 year

Secondary Outcomes (9)

  • AUC of rivaroxaban

    1 year

  • Cmax of rivaroxaban

    1 year

  • Tmax of rivaroxaban

    1 year

  • Prothrombin time (PT)

    1 year

  • Activated partial thromboplastin time (aPTT)

    1 year

  • +4 more secondary outcomes

Study Arms (1)

Rivaroxaban arm

OTHER

Pharmacokinetics / Pharmacodynamics

Drug: Rivaroxaban 10 mg

Interventions

Rivaroxaban 10 mgDRUG

Patients receive the day before the surgical intervention the first dose of Rivaroxaban (10 mg) p.o. The second tablet Rivaroxaban is administered on the third postoperative day.

Rivaroxaban arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with scheduled elective bariatric surgery : laparoscopic Roux-en-Y gastric bypass surgery or sleeve resection
  • Patient aged 18 years and older
  • BMI 35kg/m\^2 and higher
  • Women of child bearing age: willingness of using a double barrier contraception method during the study
  • Informed Consent as documented by signature

You may not qualify if:

  • Known coagulation disorders (e.g. Willebrand's disease, haemophilia)
  • Evidence for deep vein thrombosis or pulmonary embolism in the personal history or in the history of first degree relatives
  • Medical condition that is associated with an increased risk for VTE, i.e. active cancer disease, lupus erythematodes chronic inflammatory bowel disease
  • Active, clinically significant bleeding
  • Congenital or acquired bleeding disorder
  • Uncontrolled severe hypertension
  • Active gastrointestinal disease that can potentially lead to bleeding disorder: oesophagitis, gastritis, gastroesophageal reflux disease, chronic inflammatory bowel disease
  • Vascular retinopathy
  • Bronchiectasis or history of pulmonary bleeding
  • Prior stroke or TIA
  • Hereditary galactose intolerance, Lapp lactase deficiency, glucose-lactose malabsorption
  • Severe renal impairment with a creatinine clearance (GFR) of \<30ml/min
  • Positive pregnancy test, pregnancy or nursing women
  • High risk of bleeding (e.g. active ulcerative gastrointestinal disease)
  • Known intolerance of the study medication rivaroxaban
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery and Medicine, University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Obesity

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dino Kroell, ME

    University of Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 8, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

CH(1)