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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 : April 13, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Bayer
Biotronik SE & Co. KG
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Drug: Rivaroxaban Drug: Acetylsalicylic acid Phase 4

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, 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Rivaroxaban
Rivaroxaban 15 mg daily
Drug: Rivaroxaban
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
Other Names:
  • Aspirin
  • ASA



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical, overt stroke [ Time Frame: Up to 3 years ]
    Clinical, Overt stroke

  2. 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

  3. Composite of all major and minor bleeding [ Time Frame: Up to 3 years ]
    Composite of all major and minor bleeding

  4. Major bleeding only [ Time Frame: Up to 3 years ]
    Major bleeding only

  5. Minor bleeding only [ Time Frame: Up to 3 years ]
    Minor bleeding only

  6. Intracranial hemorrhage [ Time Frame: Up to 3 years ]
    Intracranial hemorrhage (clinical and covert on MRI alone)

  7. 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

  8. All-cause mortality [ Time Frame: Up to 3 years ]
    All-cause mortality

  9. 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.

  10. 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

  11. Neuropsychological testing [ Time Frame: 3 years ]
    Neuropsychological testing - performed at baseline and repeated at 3 years.

  12. Health economics [ Time Frame: 3 years ]
    Cost utilization and cost effectiveness analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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 - see section 2.3.1 for details.
  2. 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.
  3. Patient must be >18 years of age.
  4. Patient must have non-valvular AF.

Exclusion Criteria

  1. Patient does not meet all of the above listed inclusion criteria.
  2. Patient is unable or unwilling to provide informed consent.
  3. Patient is included in another randomized clinical trial or a clinical trial requiring an insurance.
  4. Patient has been on an investigational drug within 30 days of enrolment.
  5. Patient has been on strong CYP3A inducers (such as rifampicin, phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors (such as ketoconazole or protease inhibitors) within 4 days of enrolment.
  6. Patient has creatinine clearance < 30 mL/min.
  7. Patient has bleeding contra-indication to oral anticoagulation (such as bleeding diathesis, hemorrhagic disorder, significant gastrointestinal bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding history, fibrinolysis within 48 hours of enrollment).
  8. Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent (such as allergy).
  9. Patient has a contraindication to magnetic resonance imaging (MRI) or is unlikely to tolerate due to severe claustrophobia.
  10. Patients with a contraindication to implantation of an implantable loop recorder (such as limited immunocompetence or a wound healing disorder).
  11. Patient has valvular atrial fibrillation [reference AHA guidelines].
  12. Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
  13. Patient had a severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
  14. Patient with 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.
  15. Pregnancy or breastfeeding.
  16. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study.
  17. Patients who are > 85 years of age.
  18. Patients who are critically ill or who have a life expectancy <3 years.
  19. Patients for whom the investigator believes that the trial is not in the interest of the patient.

Information from the National Library of Medicine

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


Contacts
Contact: David H Birnie, MD 613-696-7269 dbirnie@ottawaheart.ca
Contact: Sonya Jancar, RN,CRA,CCRP 613-696-7000 ext 19678 ocean@ottawaheart.ca

Locations
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada
Principal Investigator: Russell D Quinn, MD         
Principal Investigator: George Wyse, MD         
Canada, British Columbia
Royal Columbian/Fraser Clinical Trials Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
Principal Investigator: J.P. LeMaitre, MD         
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Marc Deyell, MD         
Victoria Cardiac Arrhythmia Trials Inc. Recruiting
Victoria, British Columbia, Canada
Principal Investigator: Paul Novak, MD         
Principal Investigator: Richard Leather, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada
Principal Investigator: Ratika Parkash, MD         
Canada, Ontario
Hamilton Health Sciences Centre Recruiting
Hamilton, Ontario, Canada
Principal Investigator: Carlos Morillo, MD         
Principal Investigator: Jeff Healey, MD         
Kingston General Hospital Recruiting
Kingston, Ontario, Canada
Principal Investigator: Benedict Glover, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada
Principal Investigator: Allan Skanes, MD         
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada
Principal Investigator: Atul Verma, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Principal Investigator: David Birnie, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Principal Investigator: Iqwal Mangat, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Eugene Crystal, MD         
Toronto General Hospital (UHN) Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Andrew Ha, MD         
Canada, Quebec
Centre Hospitalier de L'Universite de Montreal (CHUM) Recruiting
Montreal, Quebec, Canada
Principal Investigator: Isabelle Greiss, MD         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Principal Investigator: Vidal Essebag, MD         
Montreal Health Institute Recruiting
Montreal, Quebec, Canada
Principal Investigator: Laurent Macle, MD         
Institut Universitarie de Cardiologie et de Pneumologie de Quebec Recruiting
Quebec City, Quebec, Canada
Principal Investigator: Jean Champagne, MD         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Principal Investigator: Jean-Francois Roux, MD         
China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China
Principal Investigator: Chenyang Jiang         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Bayer
Biotronik SE & Co. KG
Investigators
Principal Investigator: Atul Verma, MD Southlake Regional Health Centre
Principal Investigator: David H Birnie, MD Ottawa Heart Institute Research Corporation

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02168829     History of Changes
Other Study ID Numbers: 327494
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ottawa Heart Institute Research Corporation:
AF ablation
Anticoagulation AF ablation
Stroke prevention

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Aspirin
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Antipyretics