PK of Rivaroxaban in Bariatric Patients - Extension

Insel Gruppe AG, University Hospital Bern

Status and phase

Completed

Phase 1

Conditions

Prophylaxis of Venous Thromboembolism

Treatments

Drug: Rivaroxaban 10 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02832947

025/15_2

Details and patient eligibility

About

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

Full description

Weight loss after bariatric surgery can putatively alter drug disposition of rivaroxaban. This may be due to an altered intestinal adaptations several months after the surgical procedure. The aim of this clinical trial is to investigate pharmacokinetic and pharmacodynamic parameters after single application of 10 mg rivaroxaban in patients with prior bariatric intervention (Roux-en-y-gastric bypass or sleeve gastrectomy 6-8 months ago). PK/PD parameters will be assessed during 12 hours after application of rivaroxaban.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)