Optimal Anticoagulation for Higher Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial (OCEAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Ottawa Heart Institute Research Corporation
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Bayer
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT02168829
First received: June 18, 2014
Last updated: May 18, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
Atrial Fibrillation
Stroke
Drug: Rivaroxaban
Drug: Acetylsalicylic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • Composite of stroke, systemic embolism and covert embolic stroke as detected by cerebral MRI [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • Clinical, overt stroke [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Clinical, Overt stroke

  • Incidence of one or more covert MRI stroke(s) >15 mm [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Incidence of one or more covert MRI stroke(s) >15 mm

  • Composite of all major and minor bleeding [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Composite of all major and minor bleeding

  • Major bleeding only [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Major bleeding only

  • Minor bleeding only [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Minor bleeding only

  • Intracranial hemorrhage [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Intracranial hemorrhage (clinical and covert on MRI alone)

  • Transient ischemic attack [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    All-cause mortality

  • Net clinical benefit based on reduction in stroke/TIA rate compared to major bleeding events. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Neuropsychological testing - performed at baseline and repeated at 3 years.

  • Health economics [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Cost utilization and cost effectiveness analysis


Estimated Enrollment: 1452
Study Start Date: January 2016
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

Inclusion Criteria:

  1. 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.
  2. 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.
  3. CHA2DS2-VASc risk score of 1 or more excluding patients in whom female sex or vascular disease are their sole risk factor.
  4. Patients must be > 18 years of age.

Exclusion Criteria

  1. does not meet all of the above listed inclusion criteria.
  2. unable or unwilling to provide informed consent.
  3. included in another clinical trial
  4. GFR < 30 mL/min
  5. contraindication to oral anticoagulation (OAC)
  6. contraindication to magnetic resonance imaging (MRI)
  7. metallic prosthetic heart valve
  8. non-arrhythmic condition necessitating long-term OAC
  9. stroke within one year prior to enrolment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02168829

Contacts
Contact: David H Birnie, MD 613-761-4705 dbirnie@ottawaheart.ca

Locations
Canada, Alberta
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada
Principal Investigator: Russell D Quinn, MD         
Principal Investigator: George Wyse, MD         
Canada, British Columbia
Royal Columbian/Fraser Clinical Trials Not yet recruiting
New West Minster, British Columbia, Canada, V3L 3W4
Principal Investigator: J.P. LeMaitre, MD         
St. Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Marc Deyell, MD         
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Jason Andrade, MD         
Victoria Cardiac Arrhythmia Trials Inc. Not yet recruiting
Victoria, British Columbia, Canada
Principal Investigator: Paul Novak, MD         
Principal Investigator: Richard Leather, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Principal Investigator: Ratika Parkash, MD         
Canada, Ontario
Hamilton Health Sciences Centre Not yet recruiting
Hamilton, Ontario, Canada
Principal Investigator: Carlos Morillo, MD         
Principal Investigator: Jeff Healey, MD         
Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada
Principal Investigator: Damian Redfearn, MD         
London Health Sciences Centre Not yet 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 Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Principal Investigator: David Birnie, MD         
St. Michael's Hospital Not yet 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) Not yet recruiting
Montreal, Quebec, Canada
Principal Investigator: Isabelle Greiss, MD         
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada
Principal Investigator: Vidal Essebag, MD         
Montreal Health Institute Not yet recruiting
Montreal, Quebec, Canada
Principal Investigator: Laurent Macle, MD         
Institut Universitarie de Cardiologie et de Pneumologie de Quebec Not yet recruiting
Quebec City, Quebec, Canada
Principal Investigator: Jean Champagne, MD         
Centre Hospitalier Universitaire de Sherbrooke Not yet recruiting
Sherbrooke, Quebec, Canada
Principal Investigator: Jean-Francois Roux, MD         
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
  More Information

Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02168829     History of Changes
Other Study ID Numbers: 327494 
Study First Received: June 18, 2014
Last Updated: May 18, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
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

ClinicalTrials.gov processed this record on August 30, 2016