Clinical trial NCT02832947: PK of Rivaroxaban in Bariatric Patients - Extension
Official title: Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery - The Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prophylaxis of Venous Thromboembolism
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2016-07-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: AUC of rivaroxaban
timeFrame: 1 year
measure: Cmax of rivaroxaban
timeFrame: 1 year
measure: Tmax of rivaroxaban
timeFrame: 1 year
measure: Prothrombin time (PT)
timeFrame: 1 year
measure: Activated partial thromboplastin time (aPTT)
timeFrame: 1 year
measure: Levels of Prothrombin fragment (F1+F2)
timeFrame: 1 year
measure: Levels of Thrombin-antithrombin-complexes (TAT)
timeFrame: 1 year
measure: Levels of D-Dimers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Hospital, Inselspital Berne
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Dino Kröll, MD
role: STUDY_CHAIR
References: