This trial is comparing medical approaches for stroke prevention in people who have atrial fibrillation (AF) and have undergone a successful procedure called ablation to eliminate or substantially reduce the arrhythmia. AF is normally associated with an increased risk of stroke which in many patients can be prevented with appropriate blood thinner therapy. This trial will compare a strategy of oral anticoagulant therapy after successful ablation to therapy with an aspirin per day.
This is a prospective, open-label, randomized trial to investigate whether a strategy of ongoing, long-term oral anticoagulation with rivaroxaban 15 mg daily is superior to a strategy of antiplatelet therapy, ASA 75-160 mg, alone in preventing cerebral embolic events in moderately high risk patients following successful catheter ablation for atrial fibrillation.. At least one year post-successful catheter ablation for AF or left atrial flutter/tachycardia without evidence of any clinically apparent arrhythmia recurrence based on at least one 24 hour Holter and ECG within 6 months after the last ablation procedure and at least one 24 hour Holter and ECG between 6 and 12 months post-ablation or beyond. Patient must have no atrial fibrillation, atrial flutter or atrial tachycardia \> 30 seconds detected on a minimum 48 hour Holter monitor within two months prior to enrollment. Patients will be randomized in a 1:1 fashion to ASA 75-160 mg daily or rivaroxaban 15 mg daily. Patients will be seen at 6 months, one year and every year thereafter for a minimum of 3 years. Blood chemistry tests, ECG, holters and patient quality of life questionnaires will be done annually. Cerebral MRI scanning at baseline and at three years will be done for assessment of silent cerebral infarction. MRI imaging will be performed using a specific protocol. A pre-specified subset of patients will undergo insertion of a implantable loop recorder (ILR) capable of automated AF detection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,284
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Melbourne
Melbourne, Victoria, Australia
Melbourne Health
Melbourne, Victoria, Australia
Heart Rhythm Clinic
Nedlands, Western Australia, Australia
Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI
Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI. A patient will be considered to have a covert stroke if one or more lesions \> 15 mm has been detected between the baseline, and final (3 year) MRI on T2 weighted and/or FLAIR imaging protocols.
Time frame: 3 years
Clinical, overt stroke
Clinical, Overt stroke
Time frame: Up to 3 years
Incidence of one or more covert MRI stroke(s) >15 mm
Incidence of one or more covert MRI stroke(s) \>15 mm
Time frame: Up to 3 years
Composite of all major and minor bleeding
Composite of all major and minor bleeding
Time frame: Up to 3 years
Major bleeding only
Major bleeding only
Time frame: Up to 3 years
Minor bleeding only
Minor bleeding only
Time frame: Up to 3 years
Intracranial hemorrhage
Intracranial hemorrhage (clinical and covert on MRI alone)
Time frame: Up to 3 years
Transient ischemic attack
Transient ischemic attack defined as presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting \<24 hours
Time frame: Up to 3 years
All-cause mortality
All-cause mortality
Time frame: Up to 3 years
Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events.
Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events.
Time frame: Up to 3 years
Occurrence of non-primary endpoint MRI changes from baseline to final scan
Occurrence of non-primary endpoint MRI changes from baseline to final scan including: quantification of cerebral atrophy, quantification of cerebral white matter changes, number of all new MRI lesions \> 3mm, \>5 mm, \> 15 mm, and \> 20 mm, and number of lesions detected exclusively on DW-MRI
Time frame: 3 years
Neuropsychological testing
Neuropsychological testing - performed at baseline and repeated at 3 years.
Time frame: 3 years
Health economics
Cost utilization and cost effectiveness analysis
Time frame: 3 years
Quality of life Assessment
Quality of life Assessment measured with the Quality of life scale, EQ-5D-5L
Time frame: Quality of Life is measured at Baseline and 36 months
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