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Which blood thinner best prevents stroke after AF ablation?

NCT ID NCT02168829

Disease control Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tested two blood thinners—rivaroxaban (Xarelto) and aspirin—in over 1,200 people with atrial fibrillation who had a successful ablation procedure. The goal was to see which one better prevents strokes and silent brain clots. Participants were followed for three years with MRI scans to detect hidden strokes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rivaroxaban (Xarelto) and Aspirin (ASA)
What this could lead to
If it works, this could show that a blood thinner like rivaroxaban is better than aspirin at preventing strokes in people who have had successful ablation for atrial fibrillation.
What could go wrong
This is a completed Phase 4 trial, but results may not apply to all patients. Blood thinners like rivaroxaban also increase bleeding risk, which could outweigh benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,284 people

The number who actually took part.

Started

Jan 2016

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 if the patient opts for a loop recorder as part of the study (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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Stroke

Contacts and locations

Locations

  • ASklepios

    Hamburg, Germany

  • AZ Delta campus Wilgenstraat

    Roeselare, Belgium

  • AZ Sint-Jan (Brugge)

    Bruges, Belgium

  • Algemeen Stedelijk Ziekenhuis - campus Aalst

    Aalst, Belgium

  • Arlon - Clinique du Sud-Luxembourg

    Arlon, Belgium

  • Canberra Hospital

    Canberra, Australian Capital Territory, 2605, Australia

  • Centre Hospitalier Universitaire de Liège

    Liège, Belgium

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, Canada

  • Centre Hospitalier de L'Universite de Montreal (CHUM)

    Montreal, Quebec, Canada

  • Elektrophysiologie GFO-Kliniken Bonn

    Bonn, North Rhine-Westphalia, 53225, Germany

  • Europa Ziekenhuizen - ST-ELISABETH

    Brussels, Belgium

  • Foothills Medical Centre

    Calgary, Alberta, Canada

  • Galilee Medical Centre

    Nahariya, 22100, Israel

  • Hamilton Health Sciences Centre

    Hamilton, Ontario, Canada

  • Heart Rhythm Clinic

    Nedlands, Western Australia, 6009, Australia

  • Herz- und Diabeteszentrum NRW Ruhr-Universitat Bochum

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Herzzentrum Leipzig

    Leipzig, Leipzig, 04289, Germany

  • Herzzentrum der Universitat Koln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Hôpital du Sacré-Coeur de Montreal

    Montreal, Quebec, Canada

  • Imeldaziekenhuis

    Bonheiden, Belgium

  • Institut Universitarie de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec, Canada

  • Jessa Ziekenhuis

    Hasselt, Belgium

  • Kelowna Interior Health

    Kelowna, Canada

  • Kerckhoff Klinik

    Bad Nauheim, Hesse, 61231, Germany

  • Kingston General Hospital

    Kingston, Ontario, Canada

  • Klinikum Coburg

    Coburg, Bavaria, 96450, Germany

  • London Health Sciences Centre

    London, Ontario, Canada

  • McGill University Health Centre

    Montreal, Quebec, Canada

  • Melbourne Health

    Melbourne, Victoria, 3050, Australia

  • Middelares Gent - AZ Maria Middelares

    Ghent, Belgium

  • Montreal Health Institute

    Montreal, Quebec, Canada

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, Belgium

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, Canada

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Columbian/Fraser Clinical Trials

    New Westminster, British Columbia, V3L 3W4, Canada

  • Scarborough Health Network- Rougevalley

    Toronto, Ontario, Canada

  • Segeberger Liniken

    Bad Segeberg, Schleswig-Holstein, 23795, Germany

  • Sherbrooke- Grandby site

    Granby, Quebec, Canada

  • Sint-Jean - Kliniek Sint-Jan (Brussels)

    Brussels, Belgium

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, China

  • Southlake Regional Health Centre

    Newmarket, Ontario, Canada

  • St. Mary's General Hospital

    Kitchener, Ontario, Canada

  • St. Michael's Hospital

    Toronto, Ontario, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

  • The Alfred Melbourne

    Melbourne, Victoria, 3004, Australia

  • UKSH Lubeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • Universitair Ziekenhuis Leuven, campus Gasthuisberg

    Leuven, Belgium

  • Universitares Herzzentrum Hamburg

    Hamburg, 20246, Germany

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • Victoria Cardiac Arrhythmia Trials Inc.

    Victoria, British Columbia, Canada

  • ZNA Middelheim

    Antwerp, Belgium

  • Ziekenhuis Oost-Limburg , campus St Jan

    Lanaken, Belgium

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Other studies related to the condition(s) this trial covers.