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Study on Avoiding Anticoagulation with Apixaban for Patients with Intracerebral Hemorrhage

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment strategy for patients who have experienced a spontaneous intracerebral hemorrhage, which is a type of bleeding in the brain. The study involves the use of a medication called Eliquis (also known as apixaban), which is a type of blood thinner or anticoagulant. The purpose of the study is to evaluate the effectiveness of different treatment strategies, including the use of direct oral anticoagulants like Eliquis, compared to usual care, which may involve avoiding anticoagulation altogether.

Participants in the study will be adults who have a history of a heart rhythm disorder known as atrial fibrillation and have suffered from a spontaneous intracerebral hemorrhage. The study will assess various outcomes over a period of 24 months, including the occurrence of major vascular events, overall survival, and quality of life. The study aims to determine the best approach to prevent future vascular events in these patients.

Throughout the study, participants will be monitored for any major health events, such as cardiovascular or cerebrovascular incidents, and their overall health and quality of life will be evaluated. The study will also look at specific markers of small-vessel diseases in the brain using imaging techniques like MRI. The goal is to find a balance between preventing further bleeding and reducing the risk of blood clots in patients who have experienced a brain hemorrhage.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to assess the effectiveness of different strategies to prevent future vascular events after a brain bleed.

    You will be asked to provide consent to participate, confirming your understanding and willingness to be part of the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to gather information about your medical history, including any previous brain bleeds and heart rhythm issues.

    You will undergo tests such as a brain scan (CT or MRI) to confirm your eligibility for the study.

  3. Step 3

    Randomization

    You will be randomly assigned to one of the study groups. This means you will either receive a specific treatment or follow usual care without anticoagulation.

    The treatment group may involve taking a medication called apixaban, which is a blood thinner, in the form of Eliquis 2.5 mg film-coated tablets.

  4. Step 4

    Medication administration

    If you are in the treatment group, you will take Eliquis 2.5 mg tablets by mouth. The dosage and frequency will be determined by the study team.

    The duration of taking the medication will be up to 24 months, depending on your assigned group.

  5. Step 5

    Regular follow-ups

    You will have regular follow-up visits with the study team to monitor your health and any side effects from the treatment.

    These visits will include assessments of your overall health, brain scans, and questionnaires about your quality of life.

  6. Step 6

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the outcomes of the treatment.

    This will include a review of any major health events, your level of independence, and your quality of life.

Who can join the trial?

7 criteria

  • Must be an adult (older than 18 years old, no upper age limit).
  • Have a history of paroxysmal, persistent, or long-standing non-valvular atrial fibrillation (a type of irregular heartbeat) documented on an electrocardiogram (a test that records the electrical activity of the heart).
  • Have a CHA2DS2VASc score of 2 or more, which means there is a need for long-term blood-thinning medication to prevent blood clots.
  • Have experienced a spontaneous intracerebral haemorrhage (a type of stroke caused by bleeding in the brain) documented with a brain CT or MRI scan.
  • The stroke must have occurred more than 1 month (specifically 30 days) before joining the study, with no upper time limit.
  • There must be a clinical equipoise, meaning uncertainty among doctors about the best preventive strategy to avoid future vascular events.
  • Must be affiliated with the Sécurité Sociale (a social security system).

Who cannot join the trial?

3 criteria

  • Patients who have had an intracerebral hemorrhage (bleeding inside the brain).
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Direct OAC

    refers to a type of medication known as oral anticoagulants. These medications are used to prevent blood clots from forming in the body. They work by thinning the blood, which helps reduce the risk of stroke and other serious conditions caused by blood clots. In this trial, Direct OAC is being tested to see if it is effective in patients who have had a type of stroke called an intracerebral hemorrhage.

  • LAAC

    stands for Left Atrial Appendage Closure. This is a medical procedure, not a medication, that aims to prevent blood clots from forming in a specific part of the heart called the left atrial appendage. By closing off this area, the procedure helps reduce the risk of stroke in patients who are at high risk of blood clots. In this trial, LAAC is being compared to other treatments to see how well it works in preventing strokes after an intracerebral hemorrhage.

What is already known about the treatment

  • Direct Oral Anticoagulant (OAC)

    This medication is taken orally and is currently being studied for its use in patients who have experienced an intracerebral hemorrhage, which is a type of stroke caused by bleeding in the brain. The main goal of using Direct OAC is to prevent further blood clots while minimizing the risk of additional bleeding. It works by inhibiting specific proteins in the blood that are responsible for clotting. Direct OACs are classified as anticoagulants, which are commonly known as blood thinners.

  • Left Atrial Appendage Closure (LAAC)

    This is a medical procedure rather than a medication, aimed at reducing the risk of stroke in patients with a history of intracerebral hemorrhage. The procedure involves closing off a small pouch in the heart where blood clots often form. By preventing clot formation, LAAC helps to reduce the risk of stroke without the need for long-term use of blood-thinning medications. This approach is being compared to usual care strategies to determine its effectiveness and safety.

Investigated diseases

Intracerebral Hemorrhage – Intracerebral hemorrhage is a type of stroke caused by bleeding within the brain tissue itself. This bleeding can occur suddenly and is often due to the rupture of a blood vessel. As blood accumulates, it can increase pressure on the brain, leading to damage of brain cells. The progression of the condition can result in symptoms such as sudden headache, weakness, confusion, and loss of consciousness. Over time, the bleeding may stop on its own, but the damage caused can lead to long-term neurological issues. The severity and progression depend on the location and amount of bleeding.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514094-22-00Protocol code2016_77Estimated enrolment300 patientsSponsorCentre Hospitalier Universitaire De Lille

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