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New blood thinners may be safer after heart surgery

NCT ID NCT04284839

Disease control Sponsor: Population Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This study compares newer blood thinners (DOACs) to the standard drug warfarin in patients who need anticoagulation after open-heart surgery. About 3500 adults with atrial fibrillation will be randomly assigned to receive either a DOAC or warfarin for 30 days. The main goal is to see which approach causes fewer major bleeding events.

What this could mean

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

Active substance
Direct oral anticoagulants (DOACs) such as apixaban, dabigatran, edoxaban, or rivaroxaban, compared to warfarin
What this could lead to
If DOACs prove safer, patients may have fewer major bleeding events after heart surgery while still preventing strokes.
What could go wrong
This is an early-phase trial with 3500 participants; results may not apply to all patients, and bleeding risks remain a concern.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

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. Age ≥18 years at the time of enrolment, 2. Open heart surgery in the last 10 days, 3. Atrial fibrillation requiring anticoagulation (including pre-existing or post-operative atrial fibrillation), 4. Informed consent from either the patient or a substitute decision-maker. Exclusion Criteria: 1. Mechanical valve replacement, 2. Antiphospholipid syndrome (triple positive), 3. Severe renal failure (Cockcroft-Gault equation; creatinine clearance \<15 ml/min), 4. Known significant liver disease (Child-Pugh classification B and C), 5. Left ventricular thrombus, 6. Ongoing bleeding, hemorrhagic disorders, or bleeding diathesis, 7. Known contraindication for any DOAC or VKA, 8. Women who are pregnant, breastfeeding, or of childbearing potential, 9. Surgery including left ventricular assist device implantation or cardiac transplantation, 10. Previously enrolled in this trial, 11. Follow-up not possible, 12. History of moderate or severe mitral valvular lesion (stenosis or regurgitation) that is not corrected during index cardiac surgery.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage

As listed by the trial registrant

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

Bleeding post cardiac surgery Indication for anticoagulation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Health Science Centre

    RECRUITING

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Health Sciences North Research Institute

    RECRUITING

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Heart Center Leipzig

    ACTIVE_NOT_RECRUITING

    Leipzig, Saxony, 04289, Germany

  • Hôpital Sacré-Coeur de Montréal

    RECRUITING

    Montreal, Quebec, H4J1C5, Canada

  • IUCPQ-ULaval

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Royal Melbourne Hospital, University of Melbourne

    NOT_YET_RECRUITING

    Parkville, Victoria, 3050, Australia

  • Saint John Regional Hospital

    ACTIVE_NOT_RECRUITING

    Saint John, New Brunswick, E2L4L2, Canada

  • St Vincent's Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • St. Boniface Hospital

    RECRUITING

    Winnipeg, Manitoba, R2H 2A6, Canada

  • Sunnybrook Hospital

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University Hospital Bonn Heart Center

    ACTIVE_NOT_RECRUITING

    Bonn, 53127, Germany

  • University Hospital Jena

    RECRUITING

    Jena, Thuringia, Germany, Germany

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2C8, Canada

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6T 1Z3, Canada

  • West-German Heart and Vascular Center, University of Duisburg-Essen

    NOT_YET_RECRUITING

    Essen, 45147, Germany

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