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Study on Andexanet Alfa for Patients on Factor Xa Inhibitors (Apixaban, Rivaroxaban, Edoxaban) Needing Urgent Surgery to Reduce Bleeding Risk

Fast replyRegistered 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 patients who are taking medications known as Factor Xa inhibitors, which include apixaban, rivaroxaban, and edoxaban. These medications are used to prevent blood clots but can increase the risk of bleeding. The study is investigating the use of a treatment called andexanet alfa to help control bleeding in patients who need urgent surgery or a medical procedure. The purpose of the study is to determine if andexanet alfa is effective in managing bleeding during surgery compared to the usual care provided.

Participants in the study will be randomly assigned to receive either andexanet alfa or the standard treatment, which may include a placebo. The study will monitor the effectiveness of andexanet alfa in controlling bleeding during surgery and will also track changes in the activity of the Factor Xa inhibitors from the start of the surgery to two hours afterward. The study aims to provide valuable information on how well andexanet alfa works in real-world surgical settings.

The trial will involve a series of steps, including the administration of the treatment and careful monitoring of the patient's condition during and after the surgery. The study is expected to continue until November 2026, with recruitment starting in December 2023. This research is important for improving the safety and effectiveness of surgeries for patients who are on Factor Xa inhibitors and need urgent medical attention.

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 required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the study.

    You will need to confirm that you require urgent surgery or a procedure and that you have been taking a medication known as a factor Xa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within the last 15 hours.

  2. Step 2

    Screening

    A screening process will be conducted to ensure you meet the study's criteria. This includes confirming the need for urgent surgery or procedure and the use of a factor Xa inhibitor.

    Female participants of childbearing potential will undergo a pregnancy test to ensure eligibility.

  3. Step 3

    Treatment administration

    If eligible, you will receive a treatment called andexanet alfa or usual care. Andexanet alfa is administered through an intravenous infusion, which means it is given directly into a vein.

    The goal of the treatment is to help control bleeding during your surgery or procedure.

  4. Step 4

    Surgery or procedure

    You will undergo the planned urgent surgery or procedure. The medical team will monitor your condition closely to ensure effective control of bleeding.

  5. Step 5

    Post-surgery monitoring

    After the surgery or procedure, your recovery will be monitored. This includes checking the effectiveness of the treatment in controlling bleeding.

    Your anti-FXa activity levels, which indicate the effect of the factor Xa inhibitor, will be measured at the start of the surgery and two hours after the surgery begins.

  6. Step 6

    Follow-up

    You will have follow-up visits to assess your recovery and any potential side effects from the treatment.

    These visits are important to ensure your safety and the effectiveness of the treatment you received.

Who can join the trial?

6 criteria

  • The patient needs urgent surgery or a procedure, as decided by the doctor, and needs to stop the effect of a medicine called a direct oral FXa inhibitor (like apixaban, rivaroxaban, or edoxaban).
  • The patient must have the urgent surgery or procedure within 12 hours after agreeing to join the study.
  • The surgery or procedure is expected to have a high risk of bleeding or bleeding into an important organ.
  • The patient has taken an oral FXa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within 15 hours or more before the start of the surgery or procedure.
  • Female patients who can have children must have a negative pregnancy test before starting the study.
  • Patients who can have children (both male and female) must agree to use very effective birth control methods.

Who cannot join the trial?

7 criteria

  • Patients who are not taking a **FXa inhibitor** medication like apixaban, rivaroxaban, or edoxaban.
  • Patients who do not need urgent surgery or a medical procedure.
  • Patients who do not have a major risk of bleeding.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population.
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Investigated drugs

Andexanet Alfa is a medication used in this clinical trial to help control bleeding in patients who are taking certain blood thinners known as Factor Xa inhibitors. When patients on these blood thinners need urgent surgery or a medical procedure, there is a risk of excessive bleeding. Andexanet Alfa works by reversing the effects of the blood thinners, helping to stop or reduce bleeding during the surgery or procedure.

What is already known about the treatment

Andexanet Alfa – Andexanet Alfa is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials to evaluate its effectiveness in reversing the effects of certain blood thinners, specifically Factor Xa inhibitors like apixaban, rivaroxaban, or edoxaban, in patients who need urgent surgery and are at high risk of bleeding. The medication works by binding to the blood thinners, effectively neutralizing their action and allowing the blood to clot normally. It is classified as a reversal agent for anticoagulants, which are medications that prevent blood clots.

Investigated diseases

Reversal of anticoagulation effect in patients on a FXa inhibitor – This condition involves the need to counteract the effects of anticoagulant medications, specifically FXa inhibitors like apixaban, rivaroxaban, or edoxaban. These medications are used to prevent blood clots but can increase the risk of bleeding, especially during urgent surgeries or procedures. The progression of this condition is characterized by the need for rapid intervention to manage bleeding risks. The anticoagulation effect must be reversed to ensure safe surgical outcomes. This process involves restoring the blood's ability to clot effectively. The condition is not classified as a rare disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501353-37-00Protocol codeD9604C00001Estimated enrolment1 021 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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