Atrial FibrillationPRiSMA-AFNCT02607371
Anticoagulation Preference by AF Patients Study
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Switzerland.
Trial summary
The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral Anticoagulants [NOACs] and, in case of NOACs, Apixaban… 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?
- VKAs, NOACs including Rivaroxaban (Xarelto, BAY59-7939) and Edoxaban
- How many people
- 198 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Aug 2015to 15 Oct 2016
- 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 in primary care / general outpatient practices and outpatient clinics in German-speaking Switzerland.
Who may be able to join
- Inclusion criteria for AF patients in both the NOAC and the VKA groups:
- Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
- Age of at least 18 years at time of study inclusion,
- Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in German language.
- Additional inclusion criterion for Group 1 (NOAC):
- Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke \& systemic embolism for at least the previous 3 months.
- Additional inclusion criterion for Group 2 (VKA):
- Continuous anticoagulation with a VKA for prevention of Stroke \& systemic embolism for at least the previous 3 months.
Who cannot join
- Participation in another study (clinical intervention / observational) within the 3 months prior to enrollment,
- Interruption of VKA/NOAC therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study
The main research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).
VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.
Read the detailed description
The objective of this study is to investigate the following research questions in a cross-sectional survey of German-speaking Swiss AF patients being treated either with a VKA or with a NOAC:
- Which attributes of a medication to prevent stroke do AF patients view as important?
- Do AF patients have a preference regarding the attributes of the medication options VKA or NOAC and, in case of NOACs, with regards to rivaroxaban attributes?
- Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?
- What is the quality of life of Swiss German-speaking AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?
- Which burden do German-speaking Swiss AF patients experience in association with their anticoagulation therapy? Are there differences in the burden of treatment (ACTS) between patients treated with VKA or with NOACs?
- Conditions
- Atrial Fibrillation
- Being tested
- VKAs, NOACs including Rivaroxaban (Xarelto, BAY59-7939), Edoxaban, Apixaban, Dabigatran-etexilate
- Keywords
- Patient treatment preference, Non-valvular Atrial Fibrillation, NOAC, VKA
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VKAsOther
VKA have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
NOACs including Rivaroxaban (Xarelto, BAY59-7939)Other
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
EdoxabanOther
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
ApixabanOther
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
Dabigatran-etexilateOther
NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 / VKA treatment | A sample of about 200 patients with nonvalvular atrial fibrillation who are treated with VKAs for at least three months at date of study inclusion Receives: Other: VKAs | |
| Cohort 2 / NOAC treatment | A sample of about 200 patients with nonvalvular atrial fibrillation who are treated with NOACs for at least three months at date of study inclusion Receives: Other: NOACs including Rivaroxaban (Xarelto, BAY59-7939); Other: Edoxaban; Other: Apixaban; Other: Dabigatran-etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview
- DCE is based on the following attributes /attribute levels:
- Frequency of intake (once/twice daily),
- Need of INR monitoring/dose adjustment (yes/no),
- Need of bridging (yes/no),
- Interactions with food/drugs (yes/no),
- Distance to treating physician (1km or 15km).
Measured: up to 4 weeks
Secondary outcomes (8)
Burden associated with anticoagulation treatment measured by the questionnaire ACTS
Measured: Baseline
Health-related quality of life measured by the SF-12 questionnaire
Variables: Physical/psychological domain according to SF-12 questionnaire
Measured: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: preferred anticoagulation treatment (agent)
Measured: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score
Measured: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA
Measured: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)
Measured: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Age
Measured: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Gender
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start27 Aug 2015
- Primary completion15 Oct 2016
- Study completion15 Oct 2016
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
- Other
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607371
- Sponsor's protocol ID
- 18242
- Acronym
- PRiSMA-AF
- Status last verified
- Sep 2017
- First submitted
- 27 Aug 2015
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study
- ClinicalTrials.gov ID
- NCT02607371
- Acronym / sponsor ID
- PRiSMA-AF / 18242
- Conditions
- Atrial Fibrillation
- Keywords
- Patient treatment preference, Non-valvular Atrial Fibrillation, NOAC, VKA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 15 Oct 2016 (actual)
- First posted
- 18 Nov 2015 (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 research question of this patient survey is to assess AF (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).
VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.
Detailed description
The objective of this study is to investigate the following research questions in a cross-sectional survey of German-speaking Swiss AF patients being treated either with a VKA or with a NOAC:
- Which attributes of a medication to prevent stroke do AF patients view as important?
- Do AF patients have a preference regarding the attributes of the medication options VKA or NOAC and, in case of NOACs, with regards to rivaroxaban attributes?
- Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?
- What is the quality of life of Swiss German-speaking AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?
- Which burden do German-speaking Swiss AF patients experience in association with their anticoagulation therapy? Are there differences in the burden of treatment (ACTS) between patients treated with VKA or with NOACs?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 / VKA treatment | – | Other: VKAsA sample of about 200 patients with nonvalvular atrial fibrillation who are treated with VKAs for at least three months at date of study inclusion |
| Cohort 2 / NOAC treatment | – | Other: NOACs including Rivaroxaban (Xarelto, BAY59-7939), Other: Edoxaban, Other: Apixaban, Other: Dabigatran-etexilateA sample of about 200 patients with nonvalvular atrial fibrillation who are treated with NOACs for at least three months at date of study inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in primary care / general outpatient practices and outpatient clinics in German-speaking Switzerland.
Key inclusion criteria (8 listed)
- Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
- Age of at least 18 years at time of study inclusion,
- Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in German language.
- Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke \& systemic embolism for at least the previous 3 months.
- Continuous anticoagulation with a VKA for prevention of Stroke \& systemic embolism for at least the previous 3 months.
Key exclusion criteria (2 listed)
- Participation in another study (clinical intervention / observational) within the 3 months prior to enrollment,
- Interruption of VKA/NOAC therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.
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 |
|---|---|---|
| VKAsVKA have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study) | Other | Cohort 1 / VKA treatment |
| NOACs including Rivaroxaban (Xarelto, BAY59-7939)NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study) | Other | Cohort 2 / NOAC treatment |
| EdoxabanNOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study) | Other | Cohort 2 / NOAC treatment |
| ApixabanNOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study) | Other | Cohort 2 / NOAC treatment |
| Dabigatran-etexilateNOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study) | Other | Cohort 2 / NOAC treatment |
Primary outcome
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview
Time frame: up to 4 weeks
* DCE is based on the following attributes /attribute levels: * Frequency of intake (once/twice daily), * Need of INR monitoring/dose adjustment (yes/no), * Need of bridging (yes/no), * Interactions with food/drugs (yes/no), * Distance to treating physician (1km or 15km).
8 secondary outcomes
Burden associated with anticoagulation treatment measured by the questionnaire ACTS
Time frame: Baseline
Health-related quality of life measured by the SF-12 questionnaire
Time frame: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: preferred anticoagulation treatment (agent)
Time frame: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score
Time frame: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA
Time frame: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)
Time frame: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Age
Time frame: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Gender
Time frame: up to 4 weeks
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 14 Sep 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 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 8 inclusion and 2 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 14 Sep 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.
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?
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview (time frame: up to 4 weeks). 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 14 Sep 2017.