PK of Rivaroxaban in Bariatric Patients - Extension

NCT ID: NCT02832947

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-10-31

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.

Conditions

Prophylaxis of Venous Thromboembolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rivaroxaban Arm

Group Type: OTHER

Rivaroxaban 10 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dino Kröll, MD

Role: STUDY_CHAIR

Insel Gruppe AG, University Hospital Bern

Locations

University Hospital, Inselspital Berne

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

025/15_2

Identifier Type: -

Identifier Source: org_study_id