DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial

NCT07011095 — Early Phase 1, Not yet recruiting, 100 participants, Population Health Research Institute

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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

Registry	NCT07011095, acronym SWITCH-AF
Status	Not yet recruiting
Phase	Early Phase 1
Study type	Interventional; randomized, factorial, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Population Health Research Institute (Other)
Conditions	Atrial Fibrillation (AF), Stroke (in Patients With Atrial Fibrillation)
Interventions	VKA, Direct Oral Anticoagulant (DOAC) (Drug)
Dates	start 2025-09-03 (estimated), primary completion 2027-02-03 (estimated), completion 2027-06-03 (estimated), first posted 2025-06-08, last updated 2025-06-08

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
VKA Arm	Experimental	Drug: VKA	Vitamin K Antagonist
DOAC Arm	Experimental	Drug: Direct Oral Anticoagulant (DOAC)	Direct oral anticoagulant (locally approved)

VKA (Drug): Warfarin
Direct Oral Anticoagulant (DOAC) (Drug), also known as Rivaroxaban (Xarelto), Dabigatran (Pradaxa), Apixaban (Eliquis): Locally approved DOACs

+Outcome measures

Primary outcomes

Feasibility - Recruitment [From site activation until the end of recruitment (approximately 24 months)]: Recruitment rate; 1 patient per month per center at 9 Canadian stroke centers

Secondary outcomes

Feasibility - Adherence to Assigned Medication [Enrollment to final visit (average 12 months)]: Proportion of participants who cross-over (i.e., vitamin K antagonist to DOAC, or DOAC to vitamin K antagonist) is <5%
Feasibility - Retention [At 6 months from randomization]: Retention of ≥95% of study participants

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Written informed consent provided.
2. Age >18 years.
3. Documented history of AF or atrial flutter.
4. Ischemic stroke while on a DOAC within 14 days prior to enrollment identified on imaging.
5. 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-

Exclusion Criteria:

1. There is strong evidence for the qualifying stroke event to be associated with permanent discontinuation of DOAC therapy (for any reason)
2. Patient is unable or unwilling to take oral anticoagulation
3. History of intracranial bleeding.
4. Patient is on chronic hemodialysis or likely to need renal replacement therapy during the course of the trial.