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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Bayer | INDUSTRY |
| Biotronik Canada Inc | INDUSTRY |
| Abbott |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Active Comparator | Rivaroxaban 15 mg daily |
|
| Acetylsalicylic acid (ASA) | Active Comparator | ASA 75-160 mg daily (if intolerant to ASA, no antiplatelet therapy will be prescribed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug |
|
| |
| Acetylsalicylic acid |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical, overt stroke | Clinical, Overt stroke | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Atul Verma, MD | Southlake Health | Principal Investigator |
| David H Birnie, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Hospital | Canberra | Australian Capital Territory | 2605 | Australia | ||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41211931 | Derived | Verma A, Birnie DH, Jiang C, Heidbuchel H, Hindricks G, Kirchhof P, Healey JS, Wang Y, Dagres N, Deyell MW, Sanders P, Pathak RK, Koopman P, Nuyens D, Novak P, Amit G, Dussault C, Makanjee B, Quinn FR, Jolly U, Iden L, Kuniss M, Sharma M, Ha A, Essebag V, Champagne J, Hill MD, Smith EE, Wells GA; OCEAN Investigators. Antithrombotic Therapy after Successful Catheter Ablation for Atrial Fibrillation. N Engl J Med. 2026 Jan 22;394(4):323-332. doi: 10.1056/NEJMoa2509688. Epub 2025 Nov 8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2026 | |
| Reset | Jun 10, 2026 |
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| INDUSTRY |
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| Drug |
|
|
| Up to 3 years |
| Composite of all major and minor bleeding | Composite of all major and minor bleeding | Up to 3 years |
| Major bleeding only | Major bleeding only | Up to 3 years |
| Minor bleeding only | Minor bleeding only | Up to 3 years |
| Intracranial hemorrhage | Intracranial hemorrhage (clinical and covert on MRI alone) | 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 | Up to 3 years |
| All-cause mortality | All-cause mortality | 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. | 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 | 3 years |
| Neuropsychological testing | Neuropsychological testing - performed at baseline and repeated at 3 years. | 3 years |
| Health economics | Cost utilization and cost effectiveness analysis | 3 years |
| Quality of life Assessment | Quality of life Assessment measured with the Quality of life scale, EQ-5D-5L | Quality of Life is measured at Baseline and 36 months |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| The Alfred Melbourne | Melbourne | Victoria | 3004 | Australia |
| Melbourne Health | Melbourne | Victoria | 3050 | Australia |
| Heart Rhythm Clinic | Nedlands | Western Australia | 6009 | 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 |
| AZ Sint-Jan (Brugge) | Bruges | Belgium |
| Europa Ziekenhuizen - ST-ELISABETH | Brussels | Belgium |
| Sint-Jean - Kliniek Sint-Jan (Brussels) | Brussels | Belgium |
| Universitair Ziekenhuis Antwerpen (UZA) | Edegem | Belgium |
| Middelares Gent - AZ Maria Middelares | Ghent | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| Jessa Ziekenhuis | Hasselt | Belgium |
| Ziekenhuis Oost-Limburg , campus St Jan | Lanaken | Belgium |
| Universitair Ziekenhuis Leuven, campus Gasthuisberg | Leuven | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium |
| AZ Delta campus Wilgenstraat | Roeselare | Belgium |
| Foothills Medical Centre | Calgary | Alberta | Canada |
| Royal Columbian/Fraser Clinical Trials | New Westminster | British Columbia | V3L 3W4 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| Victoria Cardiac Arrhythmia Trials Inc. | Victoria | British Columbia | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Hamilton Health Sciences Centre | Hamilton | Ontario | Canada |
| Kingston General Hospital | Kingston | Ontario | Canada |
| St. Mary's General Hospital | Kitchener | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Scarborough Health Network- Rougevalley | Toronto | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Sherbrooke- Grandby site | Granby | Quebec | Canada |
| Centre Hospitalier de L'Universite de Montreal (CHUM) | Montreal | Quebec | Canada |
| Hôpital du Sacré-Coeur de Montreal | Montreal | Quebec | Canada |
| McGill University Health Centre | Montreal | Quebec | Canada |
| Montreal Health Institute | Montreal | Quebec | Canada |
| Institut Universitarie de Cardiologie et de Pneumologie de Quebec | Québec | Quebec | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada |
| Kelowna Interior Health | Kelowna | Canada |
| Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China |
| Klinikum Coburg | Coburg | Bavaria | 96450 | Germany |
| Kerckhoff Klinik | Bad Nauheim | Hesse | 61231 | Germany |
| Herzzentrum Leipzig | Leipzig | Leipzig | 04289 | Germany |
| Herz- und Diabeteszentrum NRW Ruhr-Universitat Bochum | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| Elektrophysiologie GFO-Kliniken Bonn | Bonn | North Rhine-Westphalia | 53225 | Germany |
| Herzzentrum der Universitat Koln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Segeberger Liniken | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| UKSH Lubeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Universitares Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| ASklepios | Hamburg | Germany |
| Galilee Medical Centre | Nahariya | 22100 | Israel |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2026 | Jun 10, 2026 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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