Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-30 @ 2:28 PM
Study NCT ID:
NCT05044533
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of characteristics of AF participants: Quality of life (QoL) data', 'timeFrame': 'Up to 90 days'}, {'measure': 'Distribution of characteristics of AF participants: Impact of the anticoagulation treatment', 'timeFrame': 'Up to 90 days'}], 'secondaryOutcomes': [{'measure': 'Distribution of outcomes of AF participants: Timing of bleeding occurrence', 'timeFrame': 'Up to 90 days'}, {'measure': 'Distribution of outcomes of AF participants: Nature of the bleed', 'timeFrame': 'Up to 90 days'}, {'measure': 'Distribution of outcomes of AF participants: Current Bleeding treatment', 'timeFrame': 'Up to 90 days'}, {'measure': 'Distribution of outcomes of AF participants: Location of bleed', 'timeFrame': 'Up to 90 days'}, {'measure': 'Distribution of outcomes of AF participants: Documented cause of bleed', 'timeFrame': 'Up to 90 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-562247', 'Atrial Fibrillation', 'Oral Anticoagulant', 'Prospective Study', 'Quality of Life (QoL)', 'United Kingdom'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥18) who have Atrial fibrillation (AF) and are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 30 days prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Adult patients (\\>= 18 years old)\n* Patients who can understand all study information and literature to provide fully informed consent\n* Atrial fibrillation (AF) as the primary diagnosis\n* Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment\n* Receiving oral anticoagulation therapy for AF\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients with active cancer\n* Patients unable to consent for themselves\n* Patient on concomitant antiplatelet therapy'}, 'identificationModule': {'nctId': 'NCT05044533', 'acronym': 'EQUAL-AF', 'briefTitle': 'A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)', 'orgStudyIdInfo': {'id': 'CV185-770'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Participants with atrial fibrillation (AF) experiencing a bleed'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SA2 8PP', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}