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NCT Number: NCT07011095

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

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Stroke (in Patients With Atrial Fibrillation) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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-

Exclusion criteria

  • 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.

Treatment and study plan

VKA

Drug

Warfarin

Direct Oral Anticoagulant (DOAC)

Drug

Locally approved DOACs

Other names: Rivaroxaban (Xarelto), Dabigatran (Pradaxa), Apixaban (Eliquis)

Primary outcomes

  1. 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

Secondary outcomes

  1. Feasibility - Adherence to Assigned Medication

    Time frame: 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%

  2. Feasibility - Retention

    Time frame: At 6 months from randomization

    Retention of ≥95% of study participants

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Taylor, BSc.

CONTACT

[email protected]

905-521-2100

Jodi Miller, Ph.D

CONTACT

[email protected]

905-521-2100

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study 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

Acronym: SWITCH-AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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