Atrial Fibrillation (AF)Early Phase 1SWITCH-AFNCT07011095
DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial
A Early Phase 1 study testing VKA and Direct Oral Anticoagulant (DOAC) in people with Atrial Fibrillation (AF) and Stroke (in Patients With Atrial Fibrillation), run by Population Health Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Stroke (in Patients With Atrial Fibrillation)
- What is being tested?
- VKA and Direct Oral Anticoagulant (DOAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2025to 3 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Being tested
- VKA, Direct Oral Anticoagulant (DOAC)
- Keywords
- stroke, atrial fibrillation, A-Fib, SWITCH-AF, DOAC, Warfarin, Anticoagulant
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VKADrug
Warfarin
Direct Oral Anticoagulant (DOAC)Drug
Also called Rivaroxaban (Xarelto), Dabigatran (Pradaxa), Apixaban (Eliquis)
Locally approved DOACs
| Study group | Role | What they receive |
|---|---|---|
| VKA Arm | Experimental | Vitamin K Antagonist Receives: Drug: VKA |
| DOAC Arm | Experimental | Direct oral anticoagulant (locally approved) Receives: Drug: Direct Oral Anticoagulant (DOAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Recruitment rate; 1 patient per month per center at 9 Canadian stroke centers
Measured: From site activation until the end of recruitment (approximately 24 months)
Secondary outcomes (2)
Feasibility - Adherence to Assigned Medication
Proportion of participants who cross-over (i.e., vitamin K antagonist to DOAC, or DOAC to vitamin K antagonist) is <5%
Measured: Enrollment to final visit (average 12 months)
Feasibility - Retention
Retention of ≥95% of study participants
Measured: At 6 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start3 Sep 2025 (estimated)
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011095
- Sponsor's protocol ID
- SWITCH-AF - Pilot
- Acronym
- SWITCH-AF
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07011095
- Acronym / sponsor ID
- SWITCH-AF / SWITCH-AF - Pilot
- Keywords
- stroke, atrial fibrillation, A-Fib, SWITCH-AF, DOAC, Warfarin, Anticoagulant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 3 Sep 2025 (estimated)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VKA Arm | Experimental | Drug: VKAVitamin K Antagonist |
| DOAC Arm | Experimental | Drug: Direct Oral Anticoagulant (DOAC)Direct oral anticoagulant (locally approved) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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-
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VKAWarfarin | Drug | VKA Arm |
| Direct Oral Anticoagulant (DOAC)Also: Rivaroxaban (Xarelto), Dabigatran (Pradaxa), Apixaban (Eliquis)Locally approved DOACs | Drug | DOAC Arm |
Primary outcome
Feasibility - Recruitment
Time frame: From site activation until the end of recruitment (approximately 24 months)
Recruitment rate; 1 patient per month per center at 9 Canadian stroke centers
2 secondary outcomes
Feasibility - Adherence to Assigned Medication
Time frame: Enrollment to final visit (average 12 months)
Feasibility - Retention
Time frame: At 6 months from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing VKA and Direct Oral Anticoagulant (DOAC) in people with Atrial Fibrillation (AF) and Stroke (in Patients With Atrial Fibrillation), run by Population Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodi Miller, Ph.D (905-521-2100, switch-af@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment (time frame: From site activation until the end of recruitment (approximately 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.