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

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

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07011095

Acronym

SWITCH-AF

Enrollment

100

Registered

2025-06-08

Start date

2025-09-03

Completion date

2027-06-03

Last updated

2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Stroke (in Patients With Atrial Fibrillation)

Keywords

stroke, atrial fibrillation, A-Fib, SWITCH-AF, DOAC, Warfarin, Anticoagulant

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.

Interventions

DRUGVKA

Warfarin

DRUGDirect Oral Anticoagulant (DOAC)

Locally approved DOACs

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactJodi Miller, Ph.D

switch-af@phri.ca905-521-2100

Backup ContactAmanda Taylor, BSc.