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Study on Ticagrelor and Acetylsalicylic Acid for Patients with Acute Coronary Syndrome Undergoing Coronary Artery Bypass Grafting

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 patients with acute coronary syndrome, a condition where the blood supply to the heart is suddenly blocked. The study is investigating the effects of two treatments: a combination of ticagrelor and acetylsalicylic acid (commonly known as aspirin) compared to aspirin alone. The goal is to determine if the combination therapy can improve outcomes for patients who have undergone a specific type of heart surgery called coronary artery bypass grafting (CABG).

Participants in the study will be randomly assigned to receive either the dual therapy of ticagrelor and aspirin or aspirin alone. The study will monitor the participants over a period of 12 months to observe the occurrence of major adverse cardiovascular events, which include serious issues like heart attacks, strokes, or the need for additional heart procedures. The study aims to see if the combination of medications can reduce these events compared to using aspirin alone.

The trial will help to understand whether adding ticagrelor to the standard aspirin treatment can provide better protection against heart-related complications after surgery. This research is important for improving treatment strategies for patients with acute coronary syndrome who have undergone CABG, potentially leading to better long-term health outcomes.

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, ensure that written informed consent is provided. This confirms understanding and agreement to participate in the trial.

    Eligibility requires being at least 18 years old and having undergone a first-time isolated coronary artery bypass grafting (CABG) due to an episode of acute coronary syndrome within the last 6 weeks.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to gather baseline health information. This may include medical history, physical examination, and any necessary tests to confirm eligibility.

  3. Step 3

    Medication administration

    Participants will be assigned to one of two groups: one receiving dual antiplatelet therapy with ticagrelor and acetylsalicylic acid (ASA), and the other receiving ASA only.

    The medications are taken orally, following the prescribed dosage and frequency as instructed by the study team.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits will be scheduled to monitor health status and any side effects. These visits are crucial for ensuring safety and effectiveness of the treatment.

    During these visits, additional tests or assessments may be conducted as needed.

  5. Step 5

    End of study evaluation

    At the end of the 12-month study period, a final evaluation will be conducted to assess the outcomes of the treatment.

    This evaluation will focus on any major adverse cardiovascular events experienced during the study.

Who can join the trial?

4 criteria

  • Provide written informed consent, which means you agree to participate in the study after being fully informed about it.
  • Be at least 18 years old.
  • Have had your first-time isolated Coronary Artery Bypass Grafting (CABG) surgery. This is a type of heart surgery to improve blood flow to the heart.
  • The surgery must have been due to an episode of acute coronary syndrome (ACS), which includes heart conditions like heart attack or unstable chest pain, within 6 weeks before the surgery.

Who cannot join the trial?

10 criteria

  • Patients with a history of **allergic reactions** to the study medications cannot participate. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
  • Patients who have had a **stroke** in the past 6 months are not eligible. A stroke is when blood flow to a part of your brain stops, causing brain cells to die.
  • Patients with **severe liver disease** cannot join the study. The liver is an organ that helps clean your blood and digest food.
  • Patients with **active bleeding disorders** are excluded. This means conditions where your blood does not clot properly, leading to excessive bleeding.
  • Patients who are currently taking other medications that affect **blood clotting** cannot participate. Blood clotting is the process that stops bleeding by forming a clot.
  • Patients with **uncontrolled high blood pressure** are not eligible. High blood pressure is when the force of your blood against your artery walls is too high.
  • Patients who have had a **heart attack** in the past 3 months cannot join. A heart attack happens when blood flow to a part of the heart is blocked.
  • Patients with **severe kidney disease** are excluded. The kidneys are organs that filter waste from your blood.
  • Patients who are pregnant or breastfeeding cannot participate. Pregnancy is when a woman is carrying a baby, and breastfeeding is feeding a baby with milk from the breast.
  • Patients who are participating in another clinical trial are not eligible. This means being part of another study at the same time.
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Investigated drugs

  • Ticagrelor

    is a medication that helps prevent blood clots. It works by stopping platelets, which are small blood cells, from sticking together. This is important for patients who have had heart problems because it can help prevent further heart attacks or strokes. In this trial, ticagrelor is used alongside another medication to see if it can improve heart health after surgery.

  • Acetylsalicylic Acid (ASA)

    , commonly known as aspirin, is a medication that reduces pain, fever, and inflammation. It also helps prevent blood clots by making the blood less sticky. In this trial, ASA is used alone or with ticagrelor to see how well it can prevent heart problems after surgery in patients who have had heart issues.

What is already known about the treatment

  • Ticagrelor

    Ticagrelor is a medication taken orally in the form of tablets, used to prevent blood clots in patients with heart conditions. It is currently being studied in clinical trials to see if it can improve outcomes for patients who have undergone coronary artery bypass surgery. The main use of ticagrelor is to reduce the risk of major cardiovascular events, such as heart attacks, in people with acute coronary syndrome. It works by blocking a receptor on platelets, which are small blood cells that help with clotting, thus preventing them from clumping together. Ticagrelor is classified as an antiplatelet drug.

  • Acetylsalicylic Acid (ASA)

    Acetylsalicylic acid, commonly known as aspirin, is an oral medication used to relieve pain, reduce inflammation, and lower fever. In the context of heart disease, it is used to prevent blood clots and reduce the risk of heart attacks and strokes. It is being compared in clinical trials to see if combining it with ticagrelor offers better protection against cardiovascular events after heart surgery. ASA works by inhibiting an enzyme involved in the production of substances that promote inflammation and clotting. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.

Investigated diseases

Coronary Artery Disease – This condition involves the narrowing or blockage of the coronary arteries, usually due to atherosclerosis, which is the buildup of cholesterol and fatty deposits on the artery walls. As the disease progresses, the reduced blood flow can lead to chest pain, known as angina, especially during physical activity or stress. Over time, the restricted blood flow may cause damage to the heart muscle, potentially leading to a heart attack. The disease can also result in other complications such as heart failure or arrhythmias. Symptoms may vary, and some individuals may not experience noticeable signs until the disease has significantly advanced. Regular monitoring and lifestyle changes are often necessary to manage the condition effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508551-40-00Protocol codeTACSI-01Estimated enrolment2 200 patientsSponsorVaestra Goetalandsregionen

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