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Study on Apixaban and Edoxaban for Preventing Stroke in Patients with Recent Perioperative Atrial Fibrillation After Noncardiac Surgery

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 certain medications on patients who have experienced perioperative atrial fibrillation after undergoing noncardiac surgery. Atrial fibrillation is a condition where the heart beats irregularly, which can sometimes occur after surgery. The medications being studied are known as non-vitamin K oral anticoagulants (NOACs), which help prevent blood clots. The specific medications included in this study are Apixaban, Edoxaban, Rivaroxaban, and Dabigatran. These medications are taken orally, meaning they are swallowed in the form of tablets or capsules.

The purpose of the study is to compare the effects of these NOACs with no anticoagulation treatment on preventing certain health issues. These issues include non-hemorrhagic stroke, which is a type of stroke not caused by bleeding in the brain, and systemic embolism, which is when a blood clot travels through the bloodstream and causes blockages. The study also looks at vascular mortality, which refers to deaths related to blood vessel problems, and other conditions like heart attacks and blood clots in the veins.

Participants in the study will be randomly assigned to receive either one of the NOACs or no anticoagulation treatment. The study will last for a period of up to 120 days, during which the health of the participants will be monitored to see how well the medications work in preventing the mentioned health issues. The goal is to gather information that could help improve treatment options for patients who experience atrial fibrillation after surgery.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria, such as having undergone noncardiac surgery within the past 35 days and experiencing perioperative atrial fibrillation (AF).

    Participants must be in normal heart rhythm at the time of joining and meet certain age and health conditions.

  2. Step 2

    Randomization

    Participants are randomly assigned to either receive a non-vitamin K oral anticoagulant (NOAC) or no anticoagulation treatment.

    The purpose is to compare the effects of these treatments on preventing stroke and other related health issues.

  3. Step 3

    Medication administration

    If assigned to the NOAC group, participants will take one of the following medications orally: apixaban, edoxaban, rivaroxaban, or dabigatran.

    The specific dosage and frequency will be determined by the study protocol and communicated to the participant.

  4. Step 4

    Follow-up period

    Participants will be monitored over the course of the study to assess the occurrence of non-hemorrhagic stroke, systemic embolism, and other vascular events.

    Regular check-ins and assessments will be conducted to track health outcomes and any side effects.

  5. Step 5

    Study completion

    The study is expected to conclude by June 2028.

    Final evaluations will be conducted to analyze the data collected and determine the effectiveness of the treatments.

Who can join the trial?

7 criteria

  • The patient must have had non-heart-related surgery in the past 35 days. This includes either staying in the hospital overnight after surgery or having a day surgery that was significant enough to potentially cause **perioperative atrial fibrillation (AF)**, which is a type of irregular heartbeat that can happen around the time of surgery.
  • The patient must have experienced at least one episode of **clinically important perioperative AF** during or after their surgery. This means the irregular heartbeat was significant enough to be noticed and recorded by medical staff.
  • The patient must be in **sinus rhythm** at the time of joining the study. Sinus rhythm is the normal, regular rhythm of the heart.
  • The patient must meet certain **high-risk criteria** based on age and health conditions:
    • If the patient is between 55-64 years old, they must have either existing heart or blood vessel disease, recent major blood vessel surgery, a **CHA2DS2VASc score** of 3 or higher (a score used to estimate the risk of stroke), or a high level of **troponin** after surgery (a protein that indicates heart stress).
    • If the patient is between 65-74 years old, they must have either existing heart or blood vessel disease, recent blood vessel surgery, a CHA2DS2VASc score of 2 or higher, or a high level of troponin after surgery.
    • If the patient is 75 years or older, they automatically meet the criteria.
    • The patient must provide written consent to participate, meaning they agree to join the study after being informed about it.

Who cannot join the trial?

9 criteria

  • Patients who have had a recent major bleeding event, which means a significant loss of blood.
  • Patients with a history of severe liver disease, which affects how the liver functions.
  • Patients with a history of severe kidney disease, which affects how the kidneys work.
  • Patients who are currently taking other blood-thinning medications, which are drugs that prevent blood clots.
  • Patients who are pregnant or breastfeeding, as this can affect the safety of the study.
  • Patients with a known allergy to the study medication, which means their body reacts negatively to it.
  • Patients who have had a recent stroke, which is a condition where blood flow to the brain is interrupted.
  • Patients with a history of severe heart disease, which affects how the heart functions.
  • Patients who are unable to follow the study procedures, which means they cannot comply with the study requirements.
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Investigated drugs

Non-vitamin K oral anticoagulants (NOACs) are medications used to prevent blood clots. In this trial, they are being tested to see if they can reduce the risk of stroke and other serious heart-related problems in patients who have had episodes of irregular heartbeats after surgery. These medications work by making it harder for the blood to form clots, which can help prevent strokes and other complications.

What is already known about the treatment

Non-vitamin K Oral Anticoagulants (NOACs) – These medications are taken orally and are used to prevent blood clots. They are currently being studied in clinical trials for their effectiveness in preventing strokes and other cardiovascular events in patients who have experienced atrial fibrillation after surgery. NOACs work by inhibiting specific proteins in the blood that are necessary for clot formation. They are classified as anticoagulants and are an alternative to traditional blood thinners like warfarin.

Investigated diseases

Perioperative atrial fibrillation after noncardiac surgery – This condition occurs when an irregular and often rapid heart rate develops after a patient undergoes surgery that does not involve the heart. It is characterized by the upper chambers of the heart (atria) beating chaotically and out of sync with the lower chambers (ventricles). This can lead to symptoms such as palpitations, shortness of breath, and fatigue. The condition typically arises shortly after surgery and can vary in duration, sometimes resolving on its own or persisting for a longer period. It is a common complication in the postoperative period and can increase the risk of stroke and other cardiovascular issues. The progression of this condition can be influenced by factors such as the patient's age, underlying heart health, and the type of surgery performed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509142-35-00Protocol code2019-ASPIREAFEstimated enrolment2 629 patientsSponsorHamilton Health Sciences Corporation

sourced from the EU Clinical Trials Register and site verification

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