Rivaroxaban in Bariatric Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02438098
• Date of registration: 28/04/2015
• Prospective Registration: Yes
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Rivaroxaban in Bariatric Surgery
• Scientific title: Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery
• Date of first enrolment: June 2015
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02438098
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Switzerland

Contacts

• Name: Dino Kroell, ME
• Affiliation: University of Bern

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria

- Intake of oral anticoagulants (phenprocoumon, acenocoumarol, dabigatran, etexilate,
apixaban etc.) 4 weeks prior to inclusion in the study

- Application of parenteral anticoagulants (unfractionated heparin, low molecular
weight heparins, heparin derivates (fondaparinux etc.) 4 weeks prior to inclusion in
the study

- Pharmacologic platelet inhibition 4 weeks prior to inclusion in the study

- 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

- Concomitant treatment with strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole,
lopinavir, ritonavir, indinavir)

- Concomitant treatment with an P-glycoprotein inhibitor and weak or moderate CYP3A4
inhibitor (e.g. erythromycin, azithromycin, diltiazem, verapamil, quinidine,
ranolazine, dronedarone, amiodarone, felodipine)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Prophylaxis of Venous Thromboembolism

Intervention(s)

Drug: Rivaroxaban 10 mg

Primary Outcome(s)

Geometric mean ratio of rivaroxaban AUC (after surgery / before surgery) [Time Frame: 1 year]

Secondary Outcome(s)

Prothrombin fragment (F1+F2) [Time Frame: 1 year]

Prothrombin time (PT) [Time Frame: 1 year]

Activated partial thromboplastin time (aPTT) [Time Frame: 1 year]

D-Dimers [Time Frame: 1 year]

Cmax of rivaroxaban [Time Frame: 1 year]

Tmax of rivaroxaban [Time Frame: 1 year]

Thrombin generation [Time Frame: 1 year]

AUC of rivaroxaban [Time Frame: 1 year]

Thrombin-antithrombin-complexes (TAT) [Time Frame: 1 year]

Secondary ID(s)

025/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer

Centre Hospitalier Universitaire Vaudois