Atrial fibrillation (AF) increases the risk of stroke, and oral anticoagulation is strongly recommended for patients at high thromboembolic risk. However, for patients with intermediate stroke risk, defined as a CHA₂DS₂-VASc score of 1 in men or 2 in women, randomized evidence supporting anticoagulation remains limited. The SINGLE-AF trial is an investigator-initiated, multicenter, open-label, adjudicator-masked, superiority randomized trial conducted in South Korea. Eligible patients with AF and intermediate stroke risk are randomly assigned in a 1:1 ratio to receive direct oral anticoagulant (DOAC) therapy or no anticoagulant therapy. Patients assigned to anticoagulation receive a direct oral anticoagulant, primarily apixaban or rivaroxaban. Patients assigned to no anticoagulant therapy do not receive routine oral anticoagulation, although temporary anticoagulation is permitted around rhythm-control procedures when clinically indicated. The primary objective of this trial is to determine whether DOAC therapy reduces the risk of adverse clinical events compared with no anticoagulant therapy. The primary end point is a composite of stroke, systemic embolism, major bleeding, or cardiovascular death at 24 months after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,803
Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) or rivaroxaban 20mg once daily (15mg once daily if meets dose-reduction criteria) for 2 years
Severance Cardiovascular Hospital Yonsei University
Seoul, South Korea
Composite outcome
Composite outcome including stroke/systemic embolism, major bleeding, and cardiovascular death
Time frame: 24 months
Stroke
Ischemic stroke specifically refers to central nervous system infarction (brain, spinal cord, or retinal cell death attributable to ischemia) accompanied by overt symptoms, while silent infarction by definition causes no known symptoms. Stroke also broadly includes intracerebral hemorrhage and subarachnoid hemorrhage.
Time frame: 24 months
Systemic embolism
Systemic embolism refers to emboli in the arterial circulation, and defined by both clinical and objective evidence of sudden loss of end-organ perfusion.
Time frame: 24 months
Major bleeding
The International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC) definitions and bleeding assessment tool are useful for standardizing the reporting of bleeding symptoms. 1\. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
Time frame: 24 months
Cardiovascular Death
Death due to myocardial infarction, sudden cardiac death, heart failure, stroke, cardiovascular procedures, cardiovascular hemorrhage, and any case of death in which a cardiovascular cause cannot be excluded as adjudicated by a clinical events committee.
Time frame: 24 months
Clinically Relevant Non-Major Bleeding (CRNMB)
1\. Any sign or symptom of hemorrhage (e.g., more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: i. requiring medical intervention by a healthcare professional ii. leading to hospitalization or increased level of care iii. prompting a face to face (i.e., not just a telephone or electronic communication) evaluation 2. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and 1: i. Fatal bleeding, and/or ii. Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or iii. Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1) or more, or leading to transfusion of two or more units of whole blood or red cells.
Time frame: 24 months
Death
The permanent stopping of all the vital bodily activities
Time frame: 24 months
Transient ischemic attack (TIA)
TIA is brief episodes of neurological dysfunction resulting from focal cerebral ischemia not associated with permanent cerebral infarction.
Time frame: 24 months
Myocardial infarction
The definition of myocardial infarction (MI) was based on the Third Universal MI definition
Time frame: 24 months
Hospital admission
Hospital admission means admission of a covered person to a hospital as an inpatient for medically necessary and appropriate care and treatment of an Illness or Injury.
Time frame: 24 months
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