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Study on Preventing Blood Clots in Patients with New-Onset Post-Operative Atrial Fibrillation after CABG Using Apixaban and Drug Combination

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 prevention of blood clots in patients who develop atrial fibrillation, a type of irregular heartbeat, after undergoing coronary artery bypass grafting (CABG) surgery. The trial aims to evaluate the effectiveness and safety of adding oral anticoagulation (OAC) therapy to existing antiplatelet treatment. Anticoagulant medications help prevent the formation of blood clots, which can lead to serious conditions like stroke or heart attack.

The study involves several medications, including Eliquis (apixaban), Xarelto (rivaroxaban), Pradaxa (dabigatran etexilate), Lixiana (edoxaban), Brilique (ticagrelor, also known as AZD6140), Clopidogrel, Marcumar (phenprocoumon), and Aspirin (acetylsalicylic acid). Some participants will receive these medications, while others may receive a placebo. The trial will last for a period of 90 days, during which participants will take the medications orally in the form of tablets or capsules.

The purpose of the study is to determine if adding these anticoagulant medications can effectively prevent thromboembolic events, such as blood clots, while also monitoring for any major bleeding risks. Participants will be observed for any occurrences of death, stroke, heart attack, or other related conditions. The study will also assess the overall clinical benefits and any potential side effects of the treatment over a period of 180 days after the initial randomization. This research is important for improving the management of atrial fibrillation in patients who have recently undergone heart 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. Participants must be at least 18 years old and have undergone isolated coronary artery bypass grafting (CABG) for coronary artery disease.

    The condition of interest is new-onset post-operative atrial fibrillation (POAF) that lasts more than 60 minutes or occurs more than once within 7 days after the CABG surgery.

  2. Step 2

    Medication administration

    Participants receive oral anticoagulant medications to prevent blood clots. These medications include clopidogrel, apixaban, ticagrelor, rivaroxaban, dabigatran etexilate, edoxaban, and acetylsalicylic acid.

    The medications are administered in the form of film-coated tablets or hard capsules, taken orally. Dosages vary, such as Clopidogrel 75 mg, Eliquis 2.5 mg, Brilique 60 mg, Xarelto 10 mg, Pradaxa 75 mg, Lixiana 15 mg, and Aspirin 500 mg.

  3. Step 3

    Monitoring and follow-up

    Participants are monitored for the effectiveness of the treatment in preventing thromboembolic events, such as stroke or heart attack, and for safety concerning major bleeding.

    The primary effectiveness endpoint includes a composite of death, ischemic stroke, transient ischemic attack, myocardial infarction, and thromboembolism.

    The primary safety endpoint focuses on significant bleeding events.

  4. Step 4

    Evaluation at 90 and 180 days

    At 90 and 180 days after randomization, the incidence of primary effectiveness and safety endpoints is evaluated.

    Secondary endpoints include cardiovascular and non-cardiovascular mortality, incidence of bleeding, and cardiac arrhythmias.

    Participants' convenience and satisfaction with the treatment are assessed using a questionnaire at 90 days.

  5. Step 5

    Completion of the study

    The study is estimated to end by February 27, 2026. Participants' data will contribute to understanding the effectiveness and safety of anticoagulant therapy in preventing complications after CABG surgery.

Who can join the trial?

6 criteria

  • Patients must be **18 years or older**.
  • Patients must have undergone **isolated CABG** surgery. CABG stands for Coronary Artery Bypass Grafting, a type of heart surgery.
  • Patients must have developed **new-onset POAF** after the surgery. POAF stands for Post-Operative Atrial Fibrillation, which is a type of irregular heartbeat that occurs after surgery.
  • The POAF must last for more than **60 minutes** or happen more than once within **7 days** after the CABG surgery.
  • Both **male and female** patients are eligible to participate.
  • The study does not include **vulnerable populations**, which means groups that might need special protection or care.

Who cannot join the trial?

3 criteria

  • Patients who have not developed new-onset post-operative atrial fibrillation (POAF) after isolated CABG surgery. POAF is a type of irregular heartbeat that can occur after heart surgery, and CABG stands for Coronary Artery Bypass Grafting, a type of heart surgery.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Oral Anticoagulation (OAC)

    is a type of medication used to prevent blood clots. In this trial, it is being tested to see if it can help prevent thromboembolic events, which are dangerous blood clots that can occur after surgery. The study is looking at how effective and safe it is to add this medication to the usual treatment for patients who develop a specific type of irregular heartbeat called new-onset post-operative atrial fibrillation (POAF) after heart surgery known as CABG (coronary artery bypass grafting).

  • Antiplatelet Therapy

    is a treatment that helps prevent blood cells called platelets from sticking together and forming clots. This therapy is commonly used in patients who have undergone heart surgery to reduce the risk of heart attacks and strokes. In this trial, antiplatelet therapy is used as a background treatment to see how well it works in combination with oral anticoagulation for patients with new-onset POAF after CABG surgery.

What is already known about the treatment

Warfarin – Warfarin is an oral medication used to prevent blood clots by thinning the blood. It is commonly prescribed for conditions like atrial fibrillation, deep vein thrombosis, and pulmonary embolism. Warfarin works by inhibiting the synthesis of vitamin K-dependent clotting factors, which are essential for blood clot formation. It is classified as an anticoagulant and is well-documented in medical literature for its effectiveness in preventing thromboembolic events.

Investigated diseases

New-Onset Post-Operative Atrial Fibrillation after CABG – This condition occurs when a patient develops atrial fibrillation, a type of irregular heartbeat, after undergoing coronary artery bypass grafting (CABG) surgery. It is characterized by a rapid and irregular heart rate that can lead to poor blood flow. The condition typically arises shortly after the surgical procedure and can cause symptoms such as palpitations, fatigue, and shortness of breath. The irregular heartbeat may be intermittent or persistent, and it can increase the risk of stroke and other complications. Management of this condition often involves monitoring and addressing the irregular heart rhythm to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515924-35-00Protocol codePACeS, final 3.0Estimated enrolment3 200 patientsSponsorIcahn School Of Medicine At Mount Sinai

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