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New blood thinner may simplify stroke prevention after heart surgery

NCT ID NCT03702582

Disease control Sponsor: Massachusetts General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether a newer blood thinner, rivaroxaban (Xarelto), is as safe and effective as the older drug warfarin for preventing strokes in people who develop atrial fibrillation after heart surgery. About 100 adults who had open-heart surgery and then experienced a new irregular heartbeat were randomly assigned to receive either rivaroxaban or warfarin. The main goal was to see if rivaroxaban could shorten hospital stays while still preventing strokes and avoiding major bleeding.

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 warfarin (Coumadin)
What this could lead to
If rivaroxaban works as well as warfarin, it could offer a simpler, more convenient option for preventing strokes after heart surgery.
What could go wrong
This is a small, completed trial with only 100 participants, so results may not apply to everyone. Both drugs carry a risk of serious bleeding.

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

100 people

The number who actually took part.

Started

Apr 2019

Finished

Oct 2023

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: * Male or Female ≥ 18 years * At least one of the following procedures: coronary artery bypass grafting, aortic valve repair, mitral valve repair, non-mechanical aortic valve replacement, any combination of these procedures * Two or more episodes of New Onset Atrial Fibrillation (each lasting \> 20 minutes) or persistent atrial fibrillation lasting \> 24 hours (Or for \>18 hours over a 24-hour interval) * If female of child-bearing age, use of adequate contraception Exclusion Criteria: * Pre-existing paroxysmal atrial fibrillation before cardiac surgery * Pre-existing indications for therapeutic anticoagulation (Including but not limited to PE, DVT, mechanical valve) * Moderate-to-severe mitral valve stenosis not surgically corrected * Pre-existing allergy to study medications * Recent (\< 1 year) or ongoing pregnancy (Urine pregnancy test will be obtained for women of child bearing age at the time of enrollment into the study) * Stroke within 1 month prior to surgery or postoperatively prior to initiation of study drugs * Postoperative bleeding episode prior to initiation of study drug * Severe dysfunction of another organ system including GFR \< 30 ml/min, baseline INR \> 1.7, ileus or other gastrointestinal pathology hindering ability to absorb oral medications, and known coagulation pathway deficiencies * Postoperative need for non-aspirin anti-platelet therapy that cannot be discontinued when therapeutic anticoagulation is initiated * Patient taking medications with known major interactions with study drugs with no therapeutic alternatives)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage hemorrhagic disease stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation Bleeding Stroke

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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