This trial is active, not recruiting.

Condition prophylaxis of venous thromboembolism
Treatment rivaroxaban 10 mg
Phase phase 1
Sponsor University Hospital Inselspital, Berne
Collaborator University of Lausanne Hospitals
Start date February 2016
End date June 2016
Trial size 13 participants
Trial identifier NCT02832947, 025/15_2


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Primary purpose prevention
rivaroxaban 10 mg
At study month 7 (+/-1 month), patients receive at 8 a.m. a single dose of 10 mg rivaroxaban. Study specific blood tubes are sampled the same day at the indicated time points from T -1h to T 12h.

Primary Outcomes

AUC of rivaroxaban
time frame: 1 year
Cmax of rivaroxaban
time frame: 1 year
Tmax of rivaroxaban
time frame: 1 year
Prothrombin time (PT)
time frame: 1 year
Activated partial thromboplastin time (aPTT)
time frame: 1 year
Levels of Prothrombin fragment (F1+F2)
time frame: 1 year
Levels of Thrombin-antithrombin-complexes (TAT)
time frame: 1 year
Levels of D-Dimers
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery - The Extension Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Hospital Inselspital, Berne.