Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-24 @ 11:02 PM
Study NCT ID:
NCT02611635
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2015-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Patient Preference Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025101', 'term': 'Vitamin B 6'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 382}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "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)", 'timeFrame': 'up to 4 weeks after enrollment of patient'}, {'measure': "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)", 'timeFrame': 'up to 4 weeks after enrollment of patient'}, {'measure': "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)", 'timeFrame': 'up to 4 weeks after enrollment of patient'}, {'measure': "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)", 'timeFrame': 'up to 4 weeks after enrollment of patient'}, {'measure': "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).", 'timeFrame': 'up to 4 weeks after enrollment of patient'}], 'secondaryOutcomes': [{'measure': 'Patient-related burden of treatment with anticoagulants measured by the Benefit and Burden Scale of the Anti-clot Treatment Scale (ACTS)', 'timeFrame': 'Baseline'}, {'measure': "Patient's quality of life measured using the SF-12 (interview version)", 'timeFrame': 'up to 4 weeks after enrollment of patient', 'description': 'Variables: Physical/psychological domain according to SF-12 questionnaire'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Age", 'timeFrame': 'Baseline'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Gender", 'timeFrame': 'Baseline'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent)", 'timeFrame': 'Baseline'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score", 'timeFrame': 'Baseline'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA", 'timeFrame': 'Baseline'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)", 'timeFrame': 'Baseline'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Lifestyle variables", 'timeFrame': 'Baseline'}, {'measure': "Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Previous switch of anticoagulation treatment", 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-valvular Atrial Fibrillation', 'Patient treatment preference', 'NOAC', 'VKA'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "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).\n\nVKA (Waran®) will be compared to Rivaroxaban.", 'detailedDescription': '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:\n\n* Which attributes of a medication to prevent stroke do AF patients view as important?\n* 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?\n* Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?\n* What is the quality of life of Swedish AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?\n* Which burden do Swedish 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?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in primary care / internal medicine specialist practices or cardiology outpatient clinics in Sweden.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for AF patients in both the NOAC and the VKA groups:\n\n* Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),\n* Age of at least 18 years at time of study inclusion,\n* 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 Swedish language.\n\nAdditional inclusion criterion for Group 1 (NOAC):\n\n* Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke \\& systemic embolism for at least the previous 3 months.\n\nAdditional inclusion criterion for Group 2 (VKA):\n\n* Continuous anticoagulation with a VKA for prevention of Stroke \\& systemic embolism for at least the previous 3 months.\n\nExclusion Criteria:\n\nExclusion criteria for both groups:\n\n* Participation in another'}, 'identificationModule': {'nctId': 'NCT02611635', 'acronym': 'PRiSMA-AF', 'briefTitle': 'Atrial Fibrillation Patient Preference Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study.', 'orgStudyIdInfo': {'id': '18377'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VKA treatment of AF / Cohort 1', 'description': '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', 'interventionNames': ['Drug: VKA: Warfarin (Waran)']}, {'label': 'NOAC treatment of AF / Cohort 2', 'description': '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', 'interventionNames': ['Drug: NOAC: Rivaroxaban (Xarelto, BAY59-7939)', 'Drug: NOAC: Dabigatran etexilate', 'Drug: NOAC: Apixaban', 'Drug: NOAC: Edoxaban', 'Drug: NOAC: Lixiana']}], 'interventions': [{'name': 'VKA: Warfarin (Waran)', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['VKA treatment of AF / Cohort 1']}, {'name': 'NOAC: Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['NOAC treatment of AF / Cohort 2']}, {'name': 'NOAC: Dabigatran etexilate', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['NOAC treatment of AF / Cohort 2']}, {'name': 'NOAC: Apixaban', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['NOAC treatment of AF / Cohort 2']}, {'name': 'NOAC: Edoxaban', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['NOAC treatment of AF / Cohort 2']}, {'name': 'NOAC: Lixiana', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['NOAC treatment of AF / Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Sweden'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}