PK of Rivaroxaban in Bariatric Patients - Extension

Prophylaxis of Venous Thromboembolism Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery - The Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832947
• Other study ID #: 025/15_2
• Status: Completed
• Phase: Phase 1
• First received: June 17, 2016
• Last updated: April 10, 2017
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prophylaxis of Venous Thromboembolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital, Inselspital Berne	Berne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of rivaroxaban		1 year
Primary	Cmax of rivaroxaban		1 year
Primary	Tmax of rivaroxaban		1 year
Primary	Prothrombin time (PT)		1 year
Primary	Activated partial thromboplastin time (aPTT)		1 year
Primary	Levels of Prothrombin fragment (F1+F2)		1 year
Primary	Levels of Thrombin-antithrombin-complexes (TAT)		1 year
Primary	Levels of D-Dimers		1 year