Prophylaxis of Venous ThromboembolismPhase 1NCT02832947
PK of Rivaroxaban in Bariatric Patients - Extension
A Phase 1 study testing Rivaroxaban 10 mg in people with Prophylaxis of Venous Thromboembolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8 months after bariatric surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prophylaxis of Venous Thromboembolism
- What is being tested?
- Rivaroxaban 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to Oct 2016
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery - The Extension Study
Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8 months after bariatric surgery
Read the 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
- Being tested
- Rivaroxaban 10 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban Arm | Other | Not described Receives: Drug: Rivaroxaban 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of rivaroxaban
Measured: 1 year
Cmax of rivaroxaban
Measured: 1 year
Tmax of rivaroxaban
Measured: 1 year
Prothrombin time (PT)
Measured: 1 year
Activated partial thromboplastin time (aPTT)
Measured: 1 year
Levels of Prothrombin fragment (F1+F2)
Measured: 1 year
Levels of Thrombin-antithrombin-complexes (TAT)
Measured: 1 year
Levels of D-Dimers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis of Venous ThromboembolismStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Dino Kröll, MD, Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832947
- Sponsor's protocol ID
- 025/15_2
- Status last verified
- Apr 2017
- First submitted
- 17 Jun 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery - The Extension Study
- ClinicalTrials.gov ID
- NCT02832947
- Acronym / sponsor ID
- 025/15_2
- Conditions
- Prophylaxis of Venous Thromboembolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban Arm | Other | Drug: Rivaroxaban 10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 mgAt 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. | Drug | Rivaroxaban Arm |
Primary outcome
AUC of rivaroxaban
Time frame: 1 year
Cmax of rivaroxaban
Time frame: 1 year
Tmax of rivaroxaban
Time frame: 1 year
Prothrombin time (PT)
Time frame: 1 year
Activated partial thromboplastin time (aPTT)
Time frame: 1 year
Levels of Prothrombin fragment (F1+F2)
Time frame: 1 year
Levels of Thrombin-antithrombin-complexes (TAT)
Time frame: 1 year
Levels of D-Dimers
Time frame: 1 year
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 11 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Dino Kröll, MD study chair
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivaroxaban 10 mg in people with Prophylaxis of Venous Thromboembolism, run by Insel Gruppe AG, University Hospital Bern at 1 site 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 5 inclusion and 20 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC of rivaroxaban (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2017.