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, at year one 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.
- Rivaroxaban Drug
ARM 1: Kind: Experimental Label: Rivaroxaban Description: Rivaroxaban 20 mg daily (15 mg daily if indicated by creatinine clearance)
- Acetylsalicylic acid Drug
ARM 1: Kind: Experimental Label: Acetylsalicylic acid (ASA) Description: ASA 81 mg daily (if intolerant to ASA clopidogrel 75 mg daily)
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Composite of stroke, systemic embolism and silent cerebral infarction.||3 years||No|
|Secondary||Major and Minor Bleeding||Up to 3 years||Yes|
|Primary||Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI||3 years||No|
|Secondary||Clinical, overt stroke||Up to 3 years||Yes|
|Secondary||Incidence of one or more covert MRI stroke(s) >15 mm||Up to 3 years||Yes|
|Secondary||Composite of all major and minor bleeding||Up to 3 years||Yes|
|Secondary||Major bleeding only||Up to 3 years||Yes|
|Secondary||Minor bleeding only||Up to 3 years||Yes|
|Secondary||Intracranial hemorrhage||Up to 3 years||Yes|
|Secondary||Transient ischemic attack||Up to 3 years||Yes|
|Secondary||All-cause mortality||Up to 3 years||Yes|
|Secondary||Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events.||Up to 3 years||Yes|
|Secondary||Occurrence of non-primary endpoint MRI changes from baseline to final scan||3 years||No|
|Secondary||Neuropsychological testing||3 years||No|
|Secondary||Health economics||3 years||No|