PK of Rivaroxaban in Bariatric Patients - Extension

NCT02832947 | Completed Phase 1 DMC

• 1 other identifier: 025/15_2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prophylaxis of Venous Thromboembolism

Outcome Measures

Primary Outcomes (8)

• AUC of rivaroxaban

  1 year

• Cmax of rivaroxaban

  1 year

• Tmax of rivaroxaban

  1 year

• Prothrombin time (PT)

  1 year

• Activated partial thromboplastin time (aPTT)

  1 year

• Levels of Prothrombin fragment (F1+F2)

  1 year

• Levels of Thrombin-antithrombin-complexes (TAT)

  1 year

• Levels of D-Dimers

  1 year

Study Arms (1)

Rivaroxaban Arm

OTHER

Drug: Rivaroxaban 10 mg

Interventions

Rivaroxaban 10 mg 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.

Rivaroxaban Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

University Hospital, Inselspital Berne

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dino Kröll, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: July 14, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)