Multinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient atrial fibrillation occurring transiently with stress and additional stroke risk factors.
noncardiac surgery in the past 35 days, with at least an overnight hospital admission aftersurgery;
noncardiac day surgery resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator; or
acute medical illness requiring hospital admission in the past 35 days and resulting in a large enough physiological insult to be able to cause AFOTS, as judged by the local investigator;
sinus rhythm at the time of randomization;
any cardiac diagnosis as the primary reason for hospital admission;
history of documented chronic AF prior to noncardiac surgery;
need for long-term systemic anticoagulation;
ongoing need for long-term dual antiplatelet treatment;
Parallel
Non-vitamin K oral anticoagulant (NOAC)
DrugParticipants randomized to the intervention arm will be prescribed one of the following NOACs for the duration of follow-up: edoxaban 60 mg daily (dose reduction to 30 mg, if applicable), apixaban 5 mg twice daily (dose reduction to 2.5 mg, if applicable), dabigatran 110 mg twice daily, or rivaroxaban 20 mg daily (dose reduction to 15 mg, if applicable). The choice of NOAC will be left up to the participant's prescribing physician.
Incidence of Non-hemorrhagic stroke or systemic embolism
Incidence of vascular mortality, and non-fatal non-hemorrhagic stroke, myocardial infarction, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism
Incidence of vascular mortality
Incidence of non-fatal, non-hemorrhagic stroke
Incidence of Myocardial infarction
Incidence of peripheral arterial thrombosis
Incidence of composite of life-threatening, major, and critical organ bleeding
Safety objective, measured as previously done in the MANAGE trial
Incidence of major bleeding
Safety objective, measured according to the ISTH criteria
Incidence of hemorrhagic stroke
Safety objective
Hospitalization for vascular causes
Tertiary Objective
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Population Health Research Institute
Lead sponsor
Hamilton Health Sciences Corporation
Collaborator
