Rivaroxaban in Bariatric Surgery

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Bayer; Centre Hospitalier Universitaire Vaudois
• Treatments: Rivaroxaban

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)