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Study on the Effects of Ticagrelor and Rivaroxaban in Patients with Atrial Fibrillation After Coronary Stent Surgery

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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 with atrial fibrillation, a condition where the heart beats irregularly. These patients have undergone a procedure called percutaneous coronary intervention (PCI), which is a type of surgery to restore blood flow to the heart using a stent. The study is investigating the use of a single drug that prevents blood clots, known as a P2Y12 inhibitor, followed by a direct-acting oral anticoagulant (DOAC). The medications being studied include rivaroxaban, ticagrelor, edoxaban, dabigatran, apixaban, clopidogrel, prasugrel, and acetylsalicylic acid.

The purpose of the study is to assess the safety and effectiveness of this treatment approach compared to the current standard treatment, which involves using a combination of medications to prevent blood clots. The study will follow patients for a period of 15 months to monitor for any major heart or brain events, such as heart attacks or strokes, as well as any significant bleeding events. The trial will also compare the outcomes of using the P2Y12 inhibitor alone for one month, followed by the DOAC alone for a longer period, against the standard treatment that involves multiple medications over several months.

Participants in the study will receive either the new treatment approach or the standard treatment. The study will help determine if the new approach is as safe and effective as the current standard. This research is important for improving treatment options for patients with atrial fibrillation who have undergone PCI, potentially leading to better health outcomes and fewer complications.

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 criteria such as age, medical history of atrial fibrillation, and recent coronary intervention.

    Written consent is required to participate.

  2. Step 2

    Initial treatment phase

    For the first month, a single drug that prevents blood clot formation, known as a P2Y12 inhibitor, is administered.

    This medication is taken orally.

  3. Step 3

    Transition to long-term treatment

    After the initial month, the treatment shifts to a long-term regimen with a direct-acting oral anticoagulant (DOAC).

    This phase continues for the remainder of the study period.

  4. Step 4

    Standard care comparison

    The study compares the new treatment approach to the current standard care, which involves a combination of three drugs for up to one month, followed by two drugs for 6 to 12 months, and then a single drug.

    The standard care includes aspirin, a P2Y12 inhibitor, and a DOAC.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, monitoring for major cardiac or cerebral events and bleeding is conducted.

    The study duration is up to 15 months, with regular follow-ups to assess safety and effectiveness.

Who can join the trial?

5 criteria

  • Must be **18 years or older**.
  • Have a condition called **atrial fibrillation** or **flutter**, which is a type of irregular heartbeat, and need to take a specific type of blood thinner called **direct-acting oral anticoagulants (DOACs)** for at least **12 months**.
  • Have had a **successful percutaneous coronary intervention (PCI)**, which is a procedure to open up blood vessels in the heart, in at least one area within the last **7 days**, with no other areas needing treatment.
  • Must not have had any major problems after the PCI, such as new chest pain that might be due to heart issues, a blood clot in the stent, or new signs of nerve problems.
  • Must provide **written informed consent**, which means agreeing to participate in the study after understanding what it involves.

Who cannot join the trial?

5 criteria

  • Patients who have not undergone a successful PCI (a procedure to open blocked blood vessels in the heart).
  • Patients who are not indicated for treatment with a DOAC (a type of blood thinner) after receiving a sirolimus-eluting Supraflex Cruz stent.
  • Patients who are not diagnosed with AF (a condition where the heart beats irregularly).
  • 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

  • P2Y12 Inhibitor

    is a type of medication that helps prevent blood clots by stopping platelets in the blood from sticking together. In this trial, it is used as a monotherapy for one month to see if it can safely reduce the risk of bleeding and prevent major heart and brain events in patients with atrial fibrillation who have had a coronary stent implanted.

  • Direct-Acting Oral Anticoagulant (DOAC)

    is a medication that helps prevent blood clots by thinning the blood. In this study, it is used after the initial P2Y12 inhibitor monotherapy. The trial aims to determine if using DOAC alone long-term is as effective and safe as the current standard treatment, which involves a combination of medications.

What is already known about the treatment

  • P2Y12 Inhibitor

    This medication is administered orally and is used as a monotherapy for one month in patients with atrial fibrillation who have undergone successful percutaneous coronary intervention (PCI). It is currently being studied in clinical trials to evaluate its safety and effectiveness compared to standard antithrombotic therapy. The main therapeutic indication is to prevent major adverse cardiac and cerebral events. At the molecular level, it works by blocking the P2Y12 receptor on platelets, which inhibits platelet aggregation and reduces the risk of blood clots. It is classified as an antiplatelet agent.

  • Direct-Acting Oral Anticoagulant (DOAC)

    This medication is taken orally and is used as a long-term monotherapy following initial treatment with a P2Y12 inhibitor in patients with atrial fibrillation post-PCI. It is being evaluated in clinical trials for its safety and efficacy in reducing bleeding risks and preventing cardiac and cerebral events. The primary therapeutic use is to prevent blood clots. Its mechanism of action involves directly inhibiting specific clotting factors, which helps to prevent the formation of harmful clots. It is classified as an anticoagulant.

Investigated diseases

  • Atrial Fibrillation

    Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This can lead to poor blood flow and may cause symptoms like palpitations, shortness of breath, and fatigue. Over time, atrial fibrillation can increase the risk of stroke and heart failure. The condition can be persistent or occur in episodes, and its severity can vary among individuals. It often requires ongoing management to control the heart rate and reduce the risk of complications.

  • Myocardial Infarction

    Myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This is usually due to a blockage in one or more of the coronary arteries. Symptoms often include chest pain, shortness of breath, and discomfort in the upper body. The severity of a heart attack can vary, and it can lead to significant heart damage if not addressed promptly. Recovery and progression depend on the extent of the damage and the individual's overall health.

  • Stroke

    A stroke happens when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can cause brain cells to die within minutes. Symptoms may include sudden numbness, confusion, trouble speaking, and difficulty walking. Strokes can be classified as ischemic, due to a blockage, or hemorrhagic, due to bleeding. The effects of a stroke depend on the area of the brain affected and the extent of the damage. Early intervention is crucial to minimize long-term effects.

  • Stent Thrombosis

    Stent thrombosis is a rare but serious complication that occurs when a blood clot forms on a stent placed in a coronary artery. This can lead to a sudden blockage of the artery, potentially causing a heart attack. It can occur shortly after stent placement or even months later. Symptoms may include chest pain and other signs of a heart attack. The risk of stent thrombosis can be influenced by factors such as stent type, patient health, and adherence to prescribed medications.

  • Transient Ischemic Attack

    A transient ischemic attack (TIA), often called a mini-stroke, occurs when there is a temporary decrease in blood supply to part of the brain. Symptoms are similar to those of a stroke but are temporary and usually resolve within minutes to hours. TIAs do not cause permanent damage but are often a warning sign of a future stroke. They can be caused by a variety of factors, including blood clots and narrowed blood vessels. Recognizing and addressing the underlying causes of a TIA is important to prevent a full stroke.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509717-36-00Protocol codeMATRIX-2Estimated enrolment3 050 patientsSponsorInsel Gruppe AG

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