Optimal Anticoagulation for Higher Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial
- Conditions
- Atrial FibrillationStroke
- Interventions
- Registration Number
- NCT02168829
- Lead Sponsor
- Ottawa Heart Institute Research Corporation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1284
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rivaroxaban Rivaroxaban Rivaroxaban 15 mg daily Acetylsalicylic acid (ASA) Acetylsalicylic acid ASA 75-160 mg daily (if intolerant to ASA, no antiplatelet therapy will be prescribed)
- Primary Outcome Measures
Name Time Method Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI 3 years 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.
- Secondary Outcome Measures
Name Time Method Clinical, overt stroke Up to 3 years Clinical, Overt stroke
All-cause mortality Up to 3 years All-cause mortality
Health economics 3 years Cost utilization and cost effectiveness analysis
Composite of all major and minor bleeding Up to 3 years Composite of all major and minor bleeding
Minor bleeding only Up to 3 years Minor bleeding only
Transient ischemic attack Up to 3 years 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
Neuropsychological testing 3 years Neuropsychological testing - performed at baseline and repeated at 3 years.
Incidence of one or more covert MRI stroke(s) >15 mm Up to 3 years Incidence of one or more covert MRI stroke(s) \>15 mm
Major bleeding only Up to 3 years Major bleeding only
Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events. Up to 3 years Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events.
Occurrence of non-primary endpoint MRI changes from baseline to final scan 3 years 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
Intracranial hemorrhage Up to 3 years Intracranial hemorrhage (clinical and covert on MRI alone)
Trial Locations
- Locations (55)
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
Algemeen Stedelijk Ziekenhuis - campus Aalst
🇧🇪Aalst, Belgium
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, Belgium
ZNA Middelheim
🇧🇪Antwerp, Belgium
Arlon - Clinique du Sud-Luxembourg
🇧🇪Arlon, Belgium
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
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