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

Early Phase 1

Not yet recruiting

• Conditions: Atrial Fibrillation (AF); Stroke (in Patients With Atrial Fibrillation)
• Interventions: Drug: VKA; Drug: Direct Oral Anticoagulant (DOAC)

• Registration Number: NCT07011095
• Lead Sponsor: Population Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-27
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Study Start: 2025-09-03
• Primary Completion: 2027-02-03
• Study Completion: 2027-06-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
VKA Arm	VKA	Vitamin K Antagonist
DOAC Arm	Direct Oral Anticoagulant (DOAC)	Direct oral anticoagulant (locally approved)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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