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

ConditionsAtrial Fibrillation (AF)Stroke (in Patients With Atrial Fibrillation)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Factorial

Treatments tested in this trial

  • VKA

    Drug

    Warfarin

  • Direct Oral Anticoagulant (DOAC)

    Drug

    Locally approved DOACs

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: VKA ArmExperimental treatment 1 intervention
Group B: DOAC ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - Recruitment

Recruitment rate; 1 patient per month per center at 9 Canadian stroke centers

Time frame
From site activation until the end of recruitment (approximately 24 months)

Secondary outcomes

1

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%

Time frame
Enrollment to final visit (average 12 months)
2

Feasibility - Retention

Retention of ≥95% of study participants

Time frame
At 6 months from randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: