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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Ottawa Heart Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT02168829
First received: June 18, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  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 University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Composite of stroke, systemic embolism and silent cerebral infarction. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Composite of stroke, systemic embolism and silent cerebral infarction detected by cerebral MRI at 3 years. Silent cerebral infarction defined as occurrence of one or more new lesion(s) greater than or equal to 15 mm detected between the initial and final 3 year MRi on T2 weighted and/or FLAIR imaging protocols.


Secondary Outcome Measures:
  • Major and Minor Bleeding [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    1. Clinical, overt stroke.
    2. Incidence of one or more silent cerebral infarction(s) 15 mm.
    3. Composite of all major and minor bleeding
    4. Major bleeding only
    5. Minor bleeding only
    6. Intracranial hemorrhage (clinical or MRI).
    7. Transient ischemic attack defined as presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting <24 h.
    8. All-cause mortality
    9. 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 including:cerebral atrophy; cerebral white matter changes; occurrence of all new MRI lesions >/= 3 mm, >/= 5 mm, >/= 15 mm and >/= 20 mm.
    11. Neuropsychological testing
    12. Health economic analysis.


Other Outcome Measures:
  • Health Economics [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Health Economic analysis of hospital and medical resource use and associated costs.

  • Neuropsychological testing [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    CERAD memory testing, and cognitive functions tests.


Estimated Enrollment: 1452
Study Start Date: September 2014
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 20 mg daily (15 mg daily if indicated by creatinine clearance)
Drug: Rivaroxaban
Other Name: Xarelto
Active Comparator: Acetylsalicylic acid (ASA)
ASA 81 mg daily (if intolerant to ASA clopidogrel 75 mg daily)
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 20 mg daily is superior to a strategy of antiplatelet therapy, ASA 81 mg, alone in preventing cerebral embolic events in moderately high risk patients following successful catheter ablation for atrial fibrillation..

Patients 12 months or more post-successful AF ablation will be screened for recurrent AF, atrial flutter (AFL) or atrial tachycardia (AT) of greater than 30 sec using holter monitors and ECG. Further screening for non-clinically apparent AF will be performed using 7 day holter monitors within one month of randomization. Only patient with less than or equal to 30 sec of AF, AFL mor AT will be eligible for randomization.

Patients will be randomized in a 1:1 fashion to ASA 81 mg daily or rivaroxaban 20 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least one year post-successful catheter ablation for AF or left atrial arrhythmia. Successful AF ablation is defined as no AF/AFL/AT >30 seconds on any pre-enrolment monitoring
  • CHADS2 risk score of 1 or more. Patients with CHADS2 score of 0, but who are >65 years old, or who are female with vascular disease will also be included
  • > 18 years of age

Exclusion Criteria:

  • does not meet all of the above listed inclusion criteria.
  • unable or unwilling to provide informed consent.
  • included in another clinical trial
  • GFR < 30 mL/min
  • contraindication to oral anticoagulation (OAC)
  • metallic prosthetic heart valve
  • non-arrhythmic condition necessitating long-term OAC
  • 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: Karen MacDonald, RN 613-798-5555 ext 17077 kmacdonald@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
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 Not yet 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         
Toronto General Hospital (UHN) Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Andrew Ha, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Eugene Crystal, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada
Principal Investigator: Iqwal Mangat, MD         
Canada, Quebec
Montreal Health Institute Not yet recruiting
Montreal, Quebec, Canada
Principal Investigator: Laurent Macle, MD         
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         
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
University of Ottawa Heart Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Atul Verma, MD Southlake Regional Health Centre
Principal Investigator: David H Birnie, MD University of Ottawa Heart Institute
  More Information

No publications provided

Responsible Party: University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT02168829     History of Changes
Other Study ID Numbers: 327494
Study First Received: June 18, 2014
Last Updated: June 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Ottawa Heart Institute:
AF ablation
Anticoagulation AF ablation
Stroke prevention

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Aspirin
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014