Atrial FibrillationX-PRESSNCT02876718
Xarelto Evidence in Real Life of Patients' Preference and Satisfaction Study
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Taiwan.
Trial summary
The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment. Patient preferences for anticoagulant treatment attributes (convenience attributes only), based on a Discrete Choice Experiment(DCE) interview will be… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY 59-7939)
- How many people
- 253 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Aug 2016to 9 Jan 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 300 patients will be included in this study. Participating centers are either primary care practices, internal medicine specialist practices or out-patient sites/out-patient clinics
Who may be able to join
- Female and male patients ≥ 20 years of age (legal age limit in Taiwan) with a confirmed diagnosis of AF (non-valvular).
- Treatment with VKA for at least 6 weeks.
- Decision to initiate treatment with Rivaroxaban has been made as per investigator's routine treatment practice.
- Written informed consent of the patient.
- Wilingness and capability to conduct two F2F interviews.
Who cannot join
- Contraindications to the use of Rivaroxaban as outlined in the local product information .
- Concomitant treatment with any other anticoagulants.
- Participation in another study (clinical intervention/observational) within the 3 months prior to enrollment.
- Patients participating in an investigational program with interventions outside of routine clinical practice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.
The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.
Patient preferences for anticoagulant treatment attributes (convenience attributes only), based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient treatment satisfaction will be documented, measured by score differences of the Anti-Clot Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.
- Conditions
- Atrial Fibrillation
- Being tested
- 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.
Rivaroxaban (Xarelto, BAY 59-7939)Drug
No specified dosing or dosage in the study. The treatment decision falls within current practice and the prescription of the medicines is clearly separated from the decision to include the patient in the study.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban, BAY59-7939 | It is a single-arm study in which only patients who switched from a VKA to a NOAC treatment will be included. Receives: Drug: Rivaroxaban (Xarelto, BAY 59-7939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)
The preferred attributes will be assessed by a questionnaire following a discrete choice experimental design.
Measured: At 3 months
Secondary outcomes (3)
Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto)
ACTS = Anti Clot treatment Scale is a questionnaire of 17 items (13 items on burden of treatment and 4 items on the benefits of treatment)
Measured: At 0 month and at 3 months
AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)
Measured: At 3 months
Reasons for switch from VKA to Xarelto
The reasons are selected by the participant out of a qualitative list of reasons for switch from VKA to Xarelto.
Measured: At 0 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start11 Aug 2016
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
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
- 253 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
- NCT02876718
- Sponsor's protocol ID
- 18728
- Acronym
- X-PRESS
- Status last verified
- Dec 2018
- First submitted
- 22 Jul 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.
- ClinicalTrials.gov ID
- NCT02876718
- Acronym / sponsor ID
- X-PRESS / 18728
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 24 Aug 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.
The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.
Patient preferences for anticoagulant treatment attributes (convenience attributes only), based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient treatment satisfaction will be documented, measured by score differences of the Anti-Clot Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban, BAY59-7939 | – | Drug: Rivaroxaban (Xarelto, BAY 59-7939)It is a single-arm study in which only patients who switched from a VKA to a NOAC treatment will be included. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 patients will be included in this study. Participating centers are either primary care practices, internal medicine specialist practices or out-patient sites/out-patient clinics
Key inclusion criteria (5 listed)
- Female and male patients ≥ 20 years of age (legal age limit in Taiwan) with a confirmed diagnosis of AF (non-valvular).
- Treatment with VKA for at least 6 weeks.
- Decision to initiate treatment with Rivaroxaban has been made as per investigator's routine treatment practice.
- Written informed consent of the patient.
- Wilingness and capability to conduct two F2F interviews.
Key exclusion criteria (4 listed)
- Contraindications to the use of Rivaroxaban as outlined in the local product information .
- Concomitant treatment with any other anticoagulants.
- Participation in another study (clinical intervention/observational) within the 3 months prior to enrollment.
- Patients participating in an investigational program with interventions outside of routine clinical practice.
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, BAY 59-7939)No specified dosing or dosage in the study. The treatment decision falls within current practice and the prescription of the medicines is clearly separated from the decision to include the patient in the study. | Drug | Rivaroxaban, BAY59-7939 |
Primary outcome
Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)
Time frame: At 3 months
The preferred attributes will be assessed by a questionnaire following a discrete choice experimental design.
3 secondary outcomes
Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto)
Time frame: At 0 month and at 3 months
AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)
Time frame: At 3 months
Reasons for switch from VKA to Xarelto
Time frame: At 0 month
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 24 Dec 2018.
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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 Taiwan.
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 4 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 24 Dec 2018. 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 Taiwan. 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?
Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates) (time frame: At 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 24 Dec 2018.