Optimal antiCoagulation for Enhanced risk pAtients Post-catheter ablatioN for atrial fibrillation trial
Objective
For patients post catheter ablation, is rivaroxaban superior to aspirin in prevention of stroke.
Randomised, open label
Primary endpoint
Composite of stroke, systemic embolism and covert embolic stroke defined by cMRI
Inclusion Criteria
- Patient must be at least one year post-successful catheter ablation(s) for atrial fibrillation without evidence of any clinically apparent arrhythmia recurrence defined as all of the following:
No AF/AT/AFL on at least 24 hour Holter and an ECG (or equivalent) from 2-6 months after the last ablation, AND no AF/AT/AFL on at least 24 hour Holter and an ECG any time after 6 months after the last ablation AND no AF/AT/AFL on at least 24 hour Holter and ECG 2 months before enrolment in the study. The Holter/ECG within 2 months of enrolment may also serve as the Holter performed 6 months or later after the last ablation - Patient must have a CHA2DS2-VASc risk score of 1 or more. Patients in whom female sex or vascular disease are their sole risk factor may not be enrolled.
- Patient must be >18 years of age.
- Patient must have non-valvular AF.
Exclusion Criteria
- Bleeding contra-indication to oral anticoagulation, or medications with strong interactions with oral anticoagulation
- Non-arrhythmic condition necessitating long-term oral anticoagulation.
- Contraindication to magnetic resonance imaging (MRI) or is unlikely to tolerate due to severe claustrophobia.
- Contraindication to implantation of an implantable loop recorder (such as limited immunocompetence or a wound healing disorder).
- Valvular atrial fibrillation
- Severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
- Special risk factors for stroke unrelated to AF, specifically known thrombophilia/hypercoagulability, uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease.
- > 85 years of age.
- Critically ill or who have a life expectancy <3 years.
Number of Canberra Heart Rhythm patients involved in the OCEAN Study: 3
- Once enrolled, randomisation into either:
- Rivaroxaban 15mg daily
- Aspirin 75-160mg daily
- MRI at baseline, 1 year and 3 year follow up
- Subset of patients (n=500) will have implantable loop recorder inserted
