Atrial FibrillationNCT02090543
BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Germany.
Trial summary
According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Phenprocoumon (Marcumar) and Rivaroxaban (Xarelto, BAY-59 7939)
- How many people
- 647 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Oct 2014
- 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: Adult AF-patients, within 3 month of anticoagulation (VKA or rivaroxaban) therapy, recruited by GPs
Who may be able to join
- A.General Criteria (Group 1and Group2):
- diagnosed non-valvular AF
- older than 18 years
- general capability and willingness to perform a structured patient interview in German
- no participation in any other clinical or observational study over the last 3 month
- Additional criteria for Group1 (VKA-experienced):
Show all 11Show fewer
- active VKA-therapy for at least 3 month without significant interruptions
- in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.
- Additional criteria for Group2 (rivaroxaban-experienced patients):
- active rivaroxaban-therapy for at least 3 month without significant interruptions
- in case of perioperative interruption VKA treatment should not have been hold for more than two weeks.
Who cannot join
- participation in any other clinical or observational study over the last 3 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study
According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk factors for stroke. Currently there are only limited information to what extend AF patients prefer one or the other treatment option based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown which of the characteristics influences patient preference most and how this relates to a neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate their current treatment and if this leads to differences among treatment with VKAs and rivaroxaban.
- Conditions
- Atrial Fibrillation
- Being tested
- Phenprocoumon (Marcumar), Rivaroxaban (Xarelto, BAY-59 7939)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenprocoumon (Marcumar)Drug
common use, no requirements (real life situation)
Rivaroxaban (Xarelto, BAY-59 7939)Drug
common use, no requirements (real life situation)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients) Receives: Drug: Phenprocoumon (Marcumar) | |
| Group 2 | 300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients) Receives: Drug: Rivaroxaban (Xarelto, BAY-59 7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation
Attributes and values in relation to the DCE-Choice-Set. The patient will receive a "test card" with the following attributes: bridging of anticoagulation, regular anticoagulation control, limitations to eating behaviour and alcohol consumption, once vs. twice daily intake of medication, neutral comparator for quantification display of preference: distance to therapy practice
Measured: Within 1-4 weeks after patient enrollement
Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire
Measured: At study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 647 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
- NCT02090543
- Sponsor's protocol ID
- 17019
- Other IDs
- OR-ITW-01-13
- Status last verified
- Jan 2017
- First submitted
- 12 Feb 2014
- 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
- Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study
- ClinicalTrials.gov ID
- NCT02090543
- Acronym / sponsor ID
- 17019
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Mar 2014 (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.
According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk factors for stroke. Currently there are only limited information to what extend AF patients prefer one or the other treatment option based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown which of the characteristics influences patient preference most and how this relates to a neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate their current treatment and if this leads to differences among treatment with VKAs and rivaroxaban.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Phenprocoumon (Marcumar)300 AF patients, with at least 3 month of anticoagulation therapy with VKAs (VKA-experienced patients) |
| Group 2 | – | Drug: Rivaroxaban (Xarelto, BAY-59 7939)300 AF patients, with at least 3 month of rivaroxaban therapy (rivaroxaban-experienced patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult AF-patients, within 3 month of anticoagulation (VKA or rivaroxaban) therapy, recruited by GPs
Key inclusion criteria (11 listed)
- diagnosed non-valvular AF
- older than 18 years
- general capability and willingness to perform a structured patient interview in German
- no participation in any other clinical or observational study over the last 3 month
- active VKA-therapy for at least 3 month without significant interruptions
Key exclusion criteria (1 listed)
- participation in any other clinical or observational study over the last 3 month
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 |
|---|---|---|
| Phenprocoumon (Marcumar)common use, no requirements (real life situation) | Drug | Group 1 |
| Rivaroxaban (Xarelto, BAY-59 7939)common use, no requirements (real life situation) | Drug | Group 2 |
Primary outcome
A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation
Time frame: Within 1-4 weeks after patient enrollement
Attributes and values in relation to the DCE-Choice-Set. The patient will receive a "test card" with the following attributes: bridging of anticoagulation, regular anticoagulation control, limitations to eating behaviour and alcohol consumption, once vs. twice daily intake of medication, neutral comparator for quantification display of preference: distance to therapy practice
Patient relevant burden/benefit due to anticoagulation using the ACTS-questionnaire
Time frame: At study entry
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 Atrial Fibrillation, run by Bayer at 1 site in Germany.
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 11 inclusion and 1 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 Germany. 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?
A prescription of patient preferences pattern including 5 attributes for Discrete-Choice-Experiment(DCE)-design in patients with atrial fibrillation (time frame: Within 1-4 weeks after patient enrollement). The study lists 2 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 23 Jan 2017.