DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VKA, Direct Oral Anticoagulant (DOAC).
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Stroke (in Patients With Atrial Fibrillation). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug VKA
Warfarin - Drug Direct Oral Anticoagulant (DOAC)
Locally approved DOACs
Primary outcome measures
- Feasibility - Recruitment [Time frame: From site activation until the end of recruitment (approximately 24 months)]
Secondary outcome measures (2)
- Feasibility - Adherence to Assigned Medication [Time frame: Enrollment to final visit (average 12 months)]
- Feasibility - Retention [Time frame: At 6 months from randomization]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07011095 · SWITCH-AF - Pilot