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Can a blood thinner or a device prevent strokes after a brain bleed?

NCT ID NCT03243175

Disease control Sponsor: University Hospital, Lille 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at people with an irregular heartbeat (atrial fibrillation) who have had a brain bleed. Doctors are unsure if blood thinners are safe for them. The trial compares two options: the blood thinner apixaban or a procedure to close a part of the heart (left atrial appendage closure). The goal is to see which approach better prevents future strokes or bleeding events. 300 adults will take part.

What this could mean

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

Active substance
Apixaban (Eliquis) and left atrial appendage closure device
What this could lead to
If successful, this could show a safe way to prevent strokes in people with atrial fibrillation who have previously had a brain bleed.
What could go wrong
This is a phase 3 trial, but it is still recruiting and results are not yet available. The risk of another brain bleed remains a concern with any blood thinner.

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 300 people

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

Started

Jan 2019

Expected to finish

Dec 2029

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 * Adult (older than 18 years old, no upper age limit) * with a history of paroxysmal, persistent or long-standing non-valvular atrial fibrillation (documented on an electrocardiogram) * and a CHA2DS2VASc score of 2 or more who have an indication for long-term anticoagulation * who suffered from a spontaneous intracerebral haemorrhage (while being treated with oral anticoagulants or not) documented with brain CT or MRI * more than 14 days before randomization (no upper delay limit) * for whom there is a clinical equipoise regarding the choice of the best preventive strategy to avoid future vascular events. Exclusion criteria for all treatment groups * Pre-randomisation modified Rankin score of 4 or 5 * Conditions other than atrial fibrillation for which the patient requires long term anticoagulation (for example prosthetic mechanical heart valve) * Serious bleeding events within the 6 months before randomisation (except for intracerebral haemorrhage) * Life expectancy of less than 1 year * Pregnancy or breastfeeding Exclusion criteria related to the LAAC only * Contraindications due to local, anatomical reasons (such as thrombus in the left atrial appendage, infection with a risk of endocarditis) * Patients older than 85 years * CHA2DS2VASc score of 2 or 3 * Patient or attending physician are unwilling to undergo/perform intervention for LAAC Exclusion criteria related to the Direct OAC only * Chronic renal insufficiency (clearance of creatinine by Cockcroft method \< 30ml/min) * Body weight lower than 50 kg * Allergy to apixaban * Coexisting conditions predisposing to head trauma (e.g. gait disturbances, uncontrolled seizures disorders) * Patient or attending physician are unwilling to use of Direct OAC

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Conditions

The condition(s) this trial relates to.

atrial fibrillation intracerebral hemorrhage

As listed by the trial registrant

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

Atrial fibrillation Intracerebral hemorrhage Microhaemorrhage

How to take part

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

  1. The places running it

    3 sites. 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

  • CH De Tourcoing

    RECRUITING

    Tourcoing, France

  • GHICL

    RECRUITING

    Lomme, France

  • Hôpital Roger Salengro, CHU

    RECRUITING

    Lille, France

More trials for these conditions

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