PK of Rivaroxaban in Bariatric Patients - Extension

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8 months after bariatric surgery

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

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: University of Lausanne Hospitals
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• Patient with past elective bariatric surgery (Roux-en-Y gastric bypass surgery or sleeve gastrectomy 6-8 months ago)

• Patient aged 18 years and older

• BMI ≥ 35 kg/m2

• Women of child-bearing age: Willingness of using a double barrier contraception method during the study

• Written, informed consent

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)