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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03522259
Other study ID # UVCMBS003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 19, 2018
Est. completion date December 31, 2023

Study information

Verified date February 2024
Source Insel Gruppe AG, University Hospital Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. The objectives are to assess the safety and feasibility of venous thromboembolism (VTE) prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days. All clinically thromboembolic events will be assessed by ultrasound or CT, respectively, as soon as apparent. In addition, patients are screened for VTE at day 28 by ultrasound to detect clinically inapparent thromboses. In a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.


Description:

The aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. Rivaroxaban as an oral anticoagulant could be an attractive option for thromboprophylaxis compared to subcutaneous standard treatment after bariatric surgery. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable. The objectives are to assess the safety and feasibility of VTE prophylaxis and lung embolism with Rivaroxaban 10mg as an oral anticoagulant. Especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable. After bariatric surgery patients receive the study medication Xarelto 10mg QD for 7, resp. 28 days. In a subgroup of study patients (patients from the University Hospital Inselspital, Bern) PK/PD parameters are assessed following the last intake of rivaroxaban at day 28.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions - Written informed consent Exclusion Criteria: - DVT and/or PE in the patient history - Myocardial infarction, transient ischemic attack or stroke within 6 months of study entry - Uncontrolled hypertension

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban 10 MG Oral Tablet [Xarelto]
Rivaroxaban 10mg per os is started on the first postoperative day. Patients receive Rivaroxaban 10mg QD for 7days (short arm) or 28 days (long arm)

Locations

Country Name City State
Switzerland Kantonsspital Baden Baden
Switzerland Clinic Beau-Site Bern
Switzerland University Hospital, Inselspital Berne Berne

Sponsors (3)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern Bayer, Janssen Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with symptomatic or asymptomatic VTE Assessed by ultrasound 28 days
Secondary Number of patients with symptomatic VTE within 28 days after bariatric surgery Assessed by ultrasound 28 days
Secondary Number of patients with asymptomatic VTE within 28 days after bariatric surgery Assessed by ultrasound 28 days
Secondary All cause mortality within 28 days after bariatric surgery 28 days
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