Bariatric SurgeryPhase 2BARIVANCT03522259
Rivaroxaban as Thrombosis Prophylaxis in Bariatric Surgery
A Phase 2 study testing Rivaroxaban 10 MG Oral Tablet [Xarelto] in people with Bariatric Surgery, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Rivaroxaban 10 MG Oral Tablet [Xarelto]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 19 Jul 2018to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions
- Written informed consent
Who cannot join
- DVT and/or PE in the patient history
- Myocardial infarction, transient ischemic attack or stroke within 6 months of study entry
- Uncontrolled hypertension
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Kantonsspital Baden
Baden
University Hospital, Inselspital Berne
Bern, 3010
Clinic Beau-Site
Bern
About this study
Official title: BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
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.
Read more
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.
Read the detailed 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.
- Conditions
- Bariatric Surgery
- Being tested
- Rivaroxaban 10 MG Oral Tablet [Xarelto]
- Keywords
- Rivaroxaban, Thromboembolic prophylaxis, Venous thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MG Oral Tablet [Xarelto]Drug
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)
| Study group | Role | What they receive |
|---|---|---|
| A: Rivaroxaban short arm | Active comparator | 7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o. Receives: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto] |
| B: Rivaroxaban long arm | Active comparator | 28 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o.
Subgroup: PK/PD parameters are assessed following the last intake of Rivaroxaban at day 28 Receives: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with symptomatic or asymptomatic VTE
Assessed by ultrasound
Measured: 28 days
Secondary outcomes (3)
Number of patients with symptomatic VTE within 28 days after bariatric surgery
Assessed by ultrasound
Measured: 28 days
Number of patients with asymptomatic VTE within 28 days after bariatric surgery
Assessed by ultrasound
Measured: 28 days
All cause mortality within 28 days after bariatric surgery
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start19 Jul 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Guido Stirnimann, MD, Principal investigator, Berne, University Hospital, University of Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522259
- Sponsor's protocol ID
- UVCMBS003
- Acronym
- BARIVA
- Status last verified
- Nov 2024
- First submitted
- 30 Apr 2018
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kroll D, Nett PC, Rommers N, Borbely Y, Deichsel F, Nocito A, Zehetner J, Kessler U, Fringeli Y, Alberio L, Candinas D, Stirnimann G. Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315241. doi: 10.1001/jamanetworkopen.2023.15241.
PubMed 37227726Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.
PubMed 36413425
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03522259
- Acronym / sponsor ID
- BARIVA / UVCMBS003
- Conditions
- Bariatric Surgery
- Keywords
- Rivaroxaban, Thromboembolic prophylaxis, Venous thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bayer, Janssen Pharmaceuticals
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Rivaroxaban short arm | Active comparator | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]7 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o. |
| B: Rivaroxaban long arm | Active comparator | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]28 day prophylactic postop treatment after Bariatric surgery with 10mg Rivaroxaban p.o. Subgroup: PK/PD parameters are assessed following the last intake of Rivaroxaban at day 28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions
- Written informed consent
Key exclusion criteria (3 listed)
- DVT and/or PE in the patient history
- Myocardial infarction, transient ischemic attack or stroke within 6 months of study entry
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | A: Rivaroxaban short arm, B: Rivaroxaban long arm |
Primary outcome
Number of patients with symptomatic or asymptomatic VTE
Time frame: 28 days
Assessed by ultrasound
3 secondary outcomes
Number of patients with symptomatic VTE within 28 days after bariatric surgery
Time frame: 28 days
Number of patients with asymptomatic VTE within 28 days after bariatric surgery
Time frame: 28 days
All cause mortality within 28 days after bariatric surgery
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Derived from this study: PubMed 37227726Kroll D, Nett PC, Rommers N, Borbely Y, Deichsel F, Nocito A, Zehetner J, Kessler U, Fringeli Y, Alberio L, Candinas D, Stirnimann G. Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315241. doi: 10.1001/jamanetworkopen.2023.15241.
- Derived from this study: PubMed 36413425Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Stirnimann, MD principal investigator
Berne, University Hospital, University of Berne, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rivaroxaban 10 MG Oral Tablet [Xarelto] in people with Bariatric Surgery, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with symptomatic or asymptomatic VTE (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03522259, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.