Optimal Anticoagulation for Higher Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial (OCEAN)
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|ClinicalTrials.gov Identifier: NCT02168829|
Recruitment Status : Recruiting
First Posted : June 20, 2014
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Stroke||Drug: Rivaroxaban Drug: Acetylsalicylic acid||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1572 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Rivaroxaban
Rivaroxaban 15 mg daily
Other Name: Xarelto
Active Comparator: Acetylsalicylic acid (ASA)
ASA 75-160 mg daily (if intolerant to ASA, no antiplatelet therapy will be prescribed)
Drug: Acetylsalicylic acid
- Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI [ Time Frame: 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, the one year and final (3 year) MRI on T2 weighted and/or FLAIR imaging protocols.
- Clinical, overt stroke [ Time Frame: Up to 3 years ]Clinical, Overt stroke
- Incidence of one or more covert MRI stroke(s) >15 mm [ Time Frame: Up to 3 years ]Incidence of one or more covert MRI stroke(s) >15 mm
- Composite of all major and minor bleeding [ Time Frame: Up to 3 years ]Composite of all major and minor bleeding
- Major bleeding only [ Time Frame: Up to 3 years ]Major bleeding only
- Minor bleeding only [ Time Frame: Up to 3 years ]Minor bleeding only
- Intracranial hemorrhage [ Time Frame: Up to 3 years ]Intracranial hemorrhage (clinical and covert on MRI alone)
- Transient ischemic attack [ Time Frame: 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
- All-cause mortality [ Time Frame: Up to 3 years ]All-cause mortality
- Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events. [ Time Frame: 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 [ Time Frame: 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
- Neuropsychological testing [ Time Frame: 3 years ]Neuropsychological testing - performed at baseline and repeated at 3 years.
- Health economics [ Time Frame: 3 years ]Cost utilization and cost effectiveness analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168829
|Contact: David H Birnie, MDemail@example.com|
|Contact: Sonya Jancar, RN,CRA,CCRP||613-696-7000 ext firstname.lastname@example.org|
|Principal Investigator:||Atul Verma, MD||Southlake Regional Health Centre|
|Principal Investigator:||David H Birnie, MD||Ottawa Heart Institute Research Corporation|