Venous ThrombosisSATORINCT01805544
Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication
An observational study of Venous Thrombosis, run by Bayer at 1 site in France.
Trial summary
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939)
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Jun 2015
- Phase
- Observational
- 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
Study population: Patients more than 18 years old, with a diagnosis of acute DVT treated with VKA with issues, who switch from VKA to Xarelto
Who may be able to join
- Female or male subject ≥ 18 years of age,
- With a diagnosis of acute DVT treated with VKA with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
- Who intends to start rivaroxaban for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT
- With anticoagulation therapy planned for at least 3 months
Who cannot join
- Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:
- Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.1.
- Lesion or condition at significant risk of major bleeding
- Concomitant treatment with any other anticoagulant agent
- Clinically significant active bleeding
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
- Pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.
- Conditions
- Venous Thrombosis
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939)
- Keywords
- SF36 questionnaire, Anti Clot Treatment Scale, Satisfaction, Quality of Life, Rivaroxaban, Prevention & control, Pulmonary embolism
- Medical subject headings
- Venous Thrombosis, Personal Satisfaction, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | 20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
Measured: After 3 months
Secondary outcomes (5)
Change of ACTS score after 1 and 6 months of treatment
Measured: After 1 and 6 months
Continuation rate at 1, 3 and 6 months
Measured: After 1, 3 and 6 months
Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)
Measured: After 1, 3 and 6 months
Physician's satisfaction at 1, 3 and 6 months assessed by a 5-point Likert scale response ("very satisfied", "satisfied", "neutral", "unsatisfied" or "very unsatisfied")
Measured: After 1, 3 and 6 months
Patient's compliance with VKA treatment at baseline and with Xarelto treatment at 1, 3 and 6 months assessed by the investigator as good (≥80%), average (50-80%) or poor (<50%)
Measured: After 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805544
- Sponsor's protocol ID
- 16409
- Other IDs
- XA1214FR
- Acronym
- SATORI
- Status last verified
- Jan 2017
- First submitted
- 5 Mar 2013
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban
- ClinicalTrials.gov ID
- NCT01805544
- Acronym / sponsor ID
- SATORI / 16409
- Conditions
- Venous Thrombosis
- Keywords
- SF36 questionnaire, Anti Clot Treatment Scale, Satisfaction, Quality of Life, Rivaroxaban, Prevention & control, Pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- May 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Mar 2013 (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.
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | Drug: Rivaroxaban (Xarelto, BAY59-7939)20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients more than 18 years old, with a diagnosis of acute DVT treated with VKA with issues, who switch from VKA to Xarelto
Key inclusion criteria (4 listed)
- Female or male subject ≥ 18 years of age,
- With a diagnosis of acute DVT treated with VKA with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
- Who intends to start rivaroxaban for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT
- With anticoagulation therapy planned for at least 3 months
Key exclusion criteria (7 listed)
- Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:
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 (Xarelto, BAY59-7939)20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment | Drug | Rivaroxaban |
Primary outcome
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
Time frame: After 3 months
5 secondary outcomes
Change of ACTS score after 1 and 6 months of treatment
Time frame: After 1 and 6 months
Continuation rate at 1, 3 and 6 months
Time frame: After 1, 3 and 6 months
Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)
Time frame: After 1, 3 and 6 months
Physician's satisfaction at 1, 3 and 6 months assessed by a 5-point Likert scale response ("very satisfied", "satisfied", "neutral", "unsatisfied" or "very unsatisfied")
Time frame: After 1, 3 and 6 months
Patient's compliance with VKA treatment at baseline and with Xarelto treatment at 1, 3 and 6 months assessed by the investigator as good (≥80%), average (50-80%) or poor (<50%)
Time frame: After 1, 3 and 6 months
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 23 Jan 2017.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis, run by Bayer at 1 site in France.
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 4 inclusion and 7 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 23 Jan 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 France. 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.
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?
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score (time frame: After 3 months). 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 23 Jan 2017.