Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT02876718
Status:
COMPLETED
Last Update Posted:
2018-12-24
First Post:
2016-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Xarelto Evidence in Real Life of Patients' Preference and Satisfaction 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': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient preferences for anticoagulant treatment attributes (utility values obtained in Logit/Probit estimates)', 'timeFrame': 'At 3 months', 'description': 'The preferred attributes will be assessed by a questionnaire following a discrete choice experimental design.'}], 'secondaryOutcomes': [{'measure': 'Change of the Anti-clot treatment scale (ACTS) benefit and burden score from baseline (on VKA) to 3 months (on Xarelto)', 'timeFrame': 'At 0 month and at 3 months', 'description': '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)'}, {'measure': 'AF symptoms as measured by European Heart Rhythm Association (EHRA) symtoms (both severity and frequency)', 'timeFrame': 'At 3 months'}, {'measure': 'Reasons for switch from VKA to Xarelto', 'timeFrame': 'At 0 month', 'description': 'The reasons are selected by the participant out of a qualitative list of reasons for switch from VKA to Xarelto.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.\n\nPatient 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female and male patients ≥ 20 years of age (legal age limit in Taiwan) with a confirmed diagnosis of AF (non-valvular).\n* Treatment with VKA for at least 6 weeks.\n* Decision to initiate treatment with Rivaroxaban has been made as per investigator's routine treatment practice.\n* Written informed consent of the patient.\n* Wilingness and capability to conduct two F2F interviews.\n\nExclusion Criteria:\n\n* Contraindications to the use of Rivaroxaban as outlined in the local product information .\n* Concomitant treatment with any other anticoagulants.\n* Participation in another study (clinical intervention/observational) within the 3 months prior to enrollment.\n* Patients participating in an investigational program with interventions outside of routine clinical practice."}, 'identificationModule': {'nctId': 'NCT02876718', 'acronym': 'X-PRESS', 'briefTitle': "Xarelto Evidence in Real Life of Patients' Preference and Satisfaction Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study.', 'orgStudyIdInfo': {'id': '18728'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rivaroxaban, BAY59-7939', 'description': 'It is a single-arm study in which only patients who switched from a VKA to a NOAC treatment will be included.', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY 59-7939)']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto, BAY 59-7939)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Rivaroxaban, BAY59-7939']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Taiwan', 'facility': 'Many Locations'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}