Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).
VKA (Waran®) will be compared to Rivaroxaban.
The objective of this study is to investigate the following research questions in a cross-sectional survey of Swedish AF patients being treated either with a VKA or with a NOAC:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VKA treatment of AF / Cohort 1 | A sample of about 200 patients with non-valvular atrial fibrillation who are treated with VKAs for at least three months at date of study inclusion |
| |
| NOAC treatment of AF / Cohort 2 | A sample of about 200 patients with non-valvular atrial fibrillation who are treated with NOACs for at least three months at date of study inclusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VKA: Warfarin (Waran) | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Frequency of intake (once/twice daily) | up to 4 weeks after enrollment of patient | |
| AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of International normalized ratio (INR) monitoring/dose adjustment (yes/no) | up to 4 weeks after enrollment of patient | |
| AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of bridging (yes/no) | up to 4 weeks after enrollment of patient | |
| AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Interactions with food/drugs (yes/no) | up to 4 weeks after enrollment of patient | |
| AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Distance to treating physician (1km or 50km). | up to 4 weeks after enrollment of patient |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-related burden of treatment with anticoagulants measured by the Benefit and Burden Scale of the Anti-clot Treatment Scale (ACTS) | Baseline | |
| Patient's quality of life measured using the SF-12 (interview version) | Variables: Physical/psychological domain according to SF-12 questionnaire |
Not provided
Inclusion Criteria:
Inclusion criteria for AF patients in both the NOAC and the VKA groups:
Additional inclusion criterion for Group 1 (NOAC):
Additional inclusion criterion for Group 2 (VKA):
Exclusion Criteria:
Exclusion criteria for both groups:
Not provided
Not provided
Not provided
Patients in primary care / internal medicine specialist practices or cardiology outpatient clinics in Sweden.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Sweden |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D025101 | Vitamin B 6 |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| NOAC: Rivaroxaban (Xarelto, BAY59-7939) | Drug | 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) |
|
| NOAC: Dabigatran etexilate | Drug | 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) |
|
| NOAC: Apixaban | Drug | 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) |
|
| NOAC: Edoxaban | Drug | 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) |
|
| NOAC: Lixiana | Drug | 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) |
|
| up to 4 weeks after enrollment of patient |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Age | Baseline |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Gender | Baseline |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent) | Baseline |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score | Baseline |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA | Baseline |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: TTR (for VKA patients only) | Baseline |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Lifestyle variables | Baseline |
| Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Previous switch of anticoagulation treatment | Baseline |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013876 |
| Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |