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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VKA Arm | Experimental | Vitamin K Antagonist |
|
| DOAC Arm | Experimental | Direct oral anticoagulant (locally approved) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VKA | Drug | Warfarin |
| |
| Direct Oral Anticoagulant (DOAC) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | Enrollment to final visit (average 12 months) |
| Feasibility - Retention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jodi Miller, Ph.D | Contact | 905-521-2100 | switch-af@phri.ca | |
| Amanda Taylor, BSc. | Contact | 905-521-2100 | switch-af@phri.ca |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C065145 | N(4)-oleylcytosine arabinoside |
| D000069552 | Rivaroxaban |
| D000069604 | Dabigatran |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Drug |
Locally approved DOACs |
|
|
Retention of ≥95% of study participants
| At 6 months from randomization |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |