Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 5:04 PM
Study NCT ID:
NCT07011095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C065145', 'term': 'N(4)-oleylcytosine arabinoside'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'C522181', 'term': 'apixaban'}], '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'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility - Recruitment', 'timeFrame': 'From site activation until the end of recruitment (approximately 24 months)', 'description': 'Recruitment rate; 1 patient per month per center at 9 Canadian stroke centers'}], 'secondaryOutcomes': [{'measure': 'Feasibility - Adherence to Assigned Medication', 'timeFrame': 'Enrollment to final visit (average 12 months)', 'description': 'Proportion of participants who cross-over (i.e., vitamin K antagonist to DOAC, or DOAC to vitamin K antagonist) is \\<5%'}, {'measure': 'Feasibility - Retention', 'timeFrame': 'At 6 months from randomization', 'description': 'Retention of ≥95% of study participants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'atrial fibrillation', 'A-Fib', 'SWITCH-AF', 'DOAC', 'Warfarin', 'Anticoagulant'], 'conditions': ['Atrial Fibrillation (AF)', 'Stroke (in Patients With Atrial Fibrillation)']}, 'descriptionModule': {'briefSummary': 'People with atrial fibrillation who have a stroke while receiving a DOAC are at increased risk of experiencing another stroke. Physicians do not know the best medication to prevent another stroke in this group of people. Options include continuing the same DOAC, switching to another DOAC or switching to warfarin.\n\nThe investigators of the SWITCH-AF trial are trying to find out whether switching to warfarin or continuing a DOAC is better for preventing stroke.\n\nThe purpose of this study, called a pilot study, is to test the study plan and to find out whether enough participants will join a larger study that answers the question. A pilot study involves a small number of participants and it is not expected to tell us which treatment is better.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent provided.\n2. Age \\>18 years.\n3. Documented history of AF or atrial flutter.\n4. Ischemic stroke while on a DOAC within 14 days prior to enrollment identified on imaging.\n5. In the opinion of the investigator, it is safe to initiate oral anticoagulation with either a VKA or a DOAC within 24 hours of randomization-\n\nExclusion Criteria:\n\n1. There is strong evidence for the qualifying stroke event to be associated with permanent discontinuation of DOAC therapy (for any reason)\n2. Patient is unable or unwilling to take oral anticoagulation\n3. History of intracranial bleeding.\n4. Patient is on chronic hemodialysis or likely to need renal replacement therapy during the course of the trial.'}, 'identificationModule': {'nctId': 'NCT07011095', 'acronym': 'SWITCH-AF', 'briefTitle': 'DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'A Pilot Trial to Assess the Feasibility of a Multicentre, Phase IV, Prospective, Randomized, Open-label, Two-arm Study With Blinded-endpoint Evaluation to Investigate Vitamin K Antagonist (VKA) Therapy Compared With Direct Oral Anticoagulant (DOAC) Therapy in Male and Female Participants With Atrial Fibrillation and Recent Ischemic Stroke While on a DOAC', 'orgStudyIdInfo': {'id': 'SWITCH-AF - Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VKA Arm', 'description': 'Vitamin K Antagonist', 'interventionNames': ['Drug: VKA']}, {'type': 'EXPERIMENTAL', 'label': 'DOAC Arm', 'description': 'Direct oral anticoagulant (locally approved)', 'interventionNames': ['Drug: Direct Oral Anticoagulant (DOAC)']}], 'interventions': [{'name': 'VKA', 'type': 'DRUG', 'description': 'Warfarin', 'armGroupLabels': ['VKA Arm']}, {'name': 'Direct Oral Anticoagulant (DOAC)', 'type': 'DRUG', 'otherNames': ['Rivaroxaban (Xarelto)', 'Dabigatran (Pradaxa)', 'Apixaban (Eliquis)'], 'description': 'Locally approved DOACs', 'armGroupLabels': ['DOAC Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jodi Miller, Ph.D', 'role': 'CONTACT', 'email': 'switch-af@phri.ca', 'phone': '905-521-2100'}, {'name': 'Amanda Taylor, BSc.', 'role': 'CONTACT', 'email': 'switch-af@phri.ca', 'phone': '905-521-2100'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}