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

NCT02168829 | Completed Phase 4 DMC

• 1 other identifier: 327494
• Study Type: interventional
• Target: 1,284
• Locations: 6 countries
• Sites: 55

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

AF ablation; Anticoagulation AF ablation; Stroke prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Clinical, overt stroke

  Up to 3 years

• Incidence of one or more covert MRI stroke(s) >15 mm

  Up to 3 years

• Composite of all major and minor bleeding

  Up to 3 years

• Major bleeding only

  Up to 3 years

• Minor bleeding only

  Up to 3 years

Study Arms (2)

Rivaroxaban

ACTIVE COMPARATOR

Rivaroxaban 15 mg daily

Drug: Rivaroxaban

Acetylsalicylic acid (ASA)

ACTIVE COMPARATOR

ASA 75-160 mg daily (if intolerant to ASA, no antiplatelet therapy will be prescribed)

Drug: Acetylsalicylic acid

Interventions

Rivaroxaban DRUG

Also known as: Xarelto

Rivaroxaban

Acetylsalicylic acid DRUG

Also known as: Aspirin, ASA

Acetylsalicylic acid (ASA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patient must be \>18 years of age.
• Patient must have non-valvular AF.

You may not qualify if:

• Patient is unable or unwilling to provide informed consent.
• Patient is included in another randomized clinical trial or a clinical trial requiring an insurance.
• Patient has been on an investigational drug within 30 days of enrolment.
• 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.
• Patient has creatinine clearance \< 30 mL/min.
• 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).
• Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent (such as allergy).
• Patient has a contraindication to magnetic resonance imaging (MRI) or is unlikely to tolerate due to severe claustrophobia.
• Patients with a contraindication to implantation of an implantable loop recorder if the patient opts for a loop recorder as part of the study (such as limited immunocompetence or a wound healing disorder).
• Patient has valvular atrial fibrillation \[reference AHA guidelines\].
• Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation.
• Patient had a severe, disabling stroke within one year prior to enrollment or any stroke within 14 days of enrollment.
• 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.
• Pregnancy or breastfeeding.
• Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Bayer: collaborator
• Biotronik Canada Inc: collaborator
• Abbott: collaborator

Study Sites (55)

Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Melbourne

Melbourne, Victoria, 3004, Australia

Location

Melbourne Health

Melbourne, Victoria, 3050, Australia

Location

Heart Rhythm Clinic

Nedlands, Western Australia, 6009, Australia

Location

Algemeen Stedelijk Ziekenhuis - campus Aalst

Aalst, Belgium

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

Location

ZNA Middelheim

Antwerp, Belgium

Location

Arlon - Clinique du Sud-Luxembourg

Arlon, Belgium

Location

Imeldaziekenhuis

Bonheiden, Belgium

Location

AZ Sint-Jan (Brugge)

Bruges, Belgium

Location

Europa Ziekenhuizen - ST-ELISABETH

Brussels, Belgium

Location

Sint-Jean - Kliniek Sint-Jan (Brussels)

Brussels, Belgium

Location

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Belgium

Location

Middelares Gent - AZ Maria Middelares

Ghent, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Ziekenhuis Oost-Limburg , campus St Jan

Lanaken, Belgium

Location

Universitair Ziekenhuis Leuven, campus Gasthuisberg

Leuven, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Location

AZ Delta campus Wilgenstraat

Roeselare, Belgium

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Royal Columbian/Fraser Clinical Trials

New Westminster, British Columbia, V3L 3W4, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Victoria Cardiac Arrhythmia Trials Inc.

Victoria, British Columbia, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

St. Mary's General Hospital

Kitchener, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Scarborough Health Network- Rougevalley

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Sherbrooke- Grandby site

Granby, Quebec, Canada

Location

Centre Hospitalier de L'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Location

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Montreal Health Institute

Montreal, Quebec, Canada

Location

Institut Universitarie de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Kelowna Interior Health

Kelowna, Canada

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Location

Klinikum Coburg

Coburg, Bavaria, 96450, Germany

Location

Kerckhoff Klinik

Bad Nauheim, Hesse, 61231, Germany

Location

Herzzentrum Leipzig

Leipzig, Leipzig, 04289, Germany

Location

Herz- und Diabeteszentrum NRW Ruhr-Universitat Bochum

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Elektrophysiologie GFO-Kliniken Bonn

Bonn, North Rhine-Westphalia, 53225, Germany

Location

Herzzentrum der Universitat Koln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Segeberger Liniken

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

UKSH Lubeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Universitares Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

ASklepios

Hamburg, Germany

Location

Galilee Medical Centre

Nahariya, 22100, Israel

Location

Related Publications (1)

• 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.

  PMID: 41211931 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Atul Verma, MD

  Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

• David H Birnie, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: January 1, 2016
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

BE (16); DE (10); CA (22); AU (5); CN (1); IL (1)