DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial
SWITCH-AF
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
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
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. The investigators of the SWITCH-AF trial are trying to find out whether switching to warfarin or continuing a DOAC is better for preventing stroke. The 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Sep 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedStudy Start
First participant enrolled
September 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 3, 2027
June 8, 2025
June 1, 2025
1.4 years
May 27, 2025
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility - Recruitment
Recruitment rate; 1 patient per month per center at 9 Canadian stroke centers
From site activation until the end of recruitment (approximately 24 months)
Secondary Outcomes (2)
Feasibility - Adherence to Assigned Medication
Enrollment to final visit (average 12 months)
Feasibility - Retention
At 6 months from randomization
Study Arms (2)
VKA Arm
EXPERIMENTALVitamin K Antagonist
DOAC Arm
EXPERIMENTALDirect oral anticoagulant (locally approved)
Interventions
Locally approved DOACs
Eligibility Criteria
You may qualify if:
- Written informed consent provided.
- Age \>18 years.
- Documented history of AF or atrial flutter.
- Ischemic stroke while on a DOAC within 14 days prior to enrollment identified on imaging.
- 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-
You may not qualify if:
- There is strong evidence for the qualifying stroke event to be associated with permanent discontinuation of DOAC therapy (for any reason)
- Patient is unable or unwilling to take oral anticoagulation
- History of intracranial bleeding.
- Patient is on chronic hemodialysis or likely to need renal replacement therapy during the course of the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2025
First Posted
June 8, 2025
Study Start
September 3, 2025
Primary Completion (Estimated)
February 3, 2027
Study Completion (Estimated)
June 3, 2027
Last Updated
June 8, 2025
Record last verified: 2025-06