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Ticagrelor monotherapy vs ticagrelor plus acetylsalicylic acid in patients with myocardial infarction treated medically

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have experienced a myocardial infarction, commonly known as a heart attack. After a heart attack, doctors often prescribe two blood‑thinning medicines to reduce the risk of another clot; this approach is called Dual Anti Platelet Therapy. In this trial, participants receive either the blood‑thinner ticagrelor by itself or the same medicine together with a low dose of acetylsalicylic acid (often called aspirin). To keep the comparison fair, a matching placebo tablet is used in place of aspirin for those who do not take it.

The purpose of the study is to determine whether taking ticagrelor alone is as safe and effective as the standard two‑medicine regimen in preventing serious bleeding and major heart problems over one year. Participants are randomly assigned to one of the two groups and take the assigned tablets daily for twelve months, with routine check‑ups scheduled throughout the year to monitor health and any side effects.

Researchers will look at two main outcomes: first, any bleeding events classified by the Bleeding Academic Research Consortium as type 2, 3, or 5, which represent moderate to severe bleeding; and second, a combined measure that includes death from any cause, another heart attack, stroke, or the need for a procedure to open blocked heart arteries (coronary revascularization). Information on these events will be collected during the scheduled visits and recorded for analysis.

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

    Enrollment and baseline assessment

    After joining the study you will meet the study team for an initial visit. during this visit you will give informed consent, answer questions about your medical history, and undergo basic health measurements. the purpose is to confirm that you have had a myocardial infarction (heart attack) and are eligible for the trial. after the assessments you will be randomly assigned to one of two treatment groups.

  2. Step 2

    Receive study medication

    You will be given a supply of study tablets in a labeled container. each day you will take ticagrelor 180 mg taken by mouth. depending on the group you are assigned to, you will also receive either an acetylsalicylic acid (aspirin) tablet 80 mg taken by mouth, or a placebo tablet that looks identical to aspirin but contains no active medicine.

  3. Step 3

    Start daily medication

    Begin taking the tablets exactly as instructed: one ticagrelor tablet 180 mg each day, and one aspirin 80 mg tablet each day if you are in the dual‑therapy group, or one matching placebo tablet each day if you are in the monotherapy group. the medication schedule continues for a total of twelve months from the first day you start taking the tablets.

  4. Step 4

    Ongoing monitoring

    Throughout the twelve‑month period you will attend scheduled clinic visits. at each visit the study staff will check your vital signs, ask about any signs of bleeding (such as unusual bruising or blood loss), and record any other health events. you should report any symptoms of bleeding or other concerns to the study staff as soon as they occur.

  5. Step 5

    Final assessment at 12 months

    At the end of the twelve‑month treatment period you will have a final study visit. during this visit the study team will evaluate whether you experienced any major bleeding, any new heart attacks, strokes, or other cardiovascular events, and will record your overall health status. the information collected will be used to compare the safety and effectiveness of the two treatment approaches.

Who can join the trial?

6 criteria

  • Be at least 18 years old.
  • Be in the hospital because of a type 1 myocardial infarction (a heart attack caused by a blockage in a heart artery).
  • Have had a coronary angiogram, which is an X‑ray test that looks at the blood vessels of the heart.
  • Plan to receive only medication (no procedures such as stents or bypass surgery) to treat the condition.
  • Agree to join the study and attend all scheduled study visits.
  • Be expected to live for at least 12 more months.

Who cannot join the trial?

10 criteria

  • Being in the hospital because of a heart attack (myocardial infarction) of type 2‑5 or because of unstable chest pain (unstable angina) as defined by the 4th Universal Definition of Myocardial Infarction.
  • If the treating doctor decides you are not suitable for either of the study treatments.
  • Being in the hospital for a severe heart attack called ST‑Elevation Myocardial Infarction that includes a fresh clot in a major heart artery.
  • Having high levels of heart injury markers (called troponins or CK‑MB) that the doctor believes are not caused by reduced blood flow (ischemia), such as injury from a non‑heart‑attack cause, inflammation of the heart muscle (myocarditis), or stress‑related heart changes (Takotsubo syndrome).
  • Having a confirmed or suspected spontaneous tearing (dissection) of a coronary artery.
  • Needing a long‑term oral blood‑thinner (chronic oral anticoagulant) for another medical condition.
  • Having another reason, not related to the heart, that requires you to take two antiplatelet medicines at the same time (dual antiplatelet therapy).
  • Already taking any antiplatelet medicine that the doctor says must be continued and is not part of the study.
  • Having been hospitalized for a heart attack, a procedure to open a blocked artery (PCI), or heart‑bypass surgery (CABG) within the past 12 months.
  • Being allergic to, unable to tolerate, or having a medical reason not to use aspirin (ASA) or ticagrelor.
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Investigated drugs

  • TICAGRELOR

    is a pill taken by mouth that helps prevent blood clots by stopping platelets in the blood from sticking together. In this study, it is used as the main treatment being tested on its own (called monotherapy) to see if it can protect patients after a heart attack without needing another drug.

  • ACETYLSALICYLIC ACID

    , commonly known as aspirin, is also a pill taken by mouth that reduces the ability of platelets to clump together, helping to lower the risk of clot-related problems. In the trial, aspirin is used together with ticagrelor as the standard “dual antiplatelet therapy” so researchers can compare the combination to ticagrelor alone.

What is already known about the treatment

  • Ticagrelor

    This medication is taken as an oral tablet, usually 180 mg taken by mouth. It is an approved and widely used drug in medical practice, especially for patients with acute coronary syndrome or after a heart attack. Ticagrelor works by blocking the P2Y12 receptor on platelets, which stops the chemicals that make platelets stick together and form clots. It belongs to the class of antiplatelet agents known as P2Y12 receptor antagonists.

  • Acetylsalicylic acid

    This drug is also taken orally, commonly as an 80 mg tablet swallowed with water. It is a long‑standing, over‑the‑counter medication that is well documented in medical literature for heart‑protective use. Acetylsalicylic acid reduces clotting by permanently inhibiting the COX‑1 enzyme, which lowers the production of a substance that makes platelets clump. It is classified as a non‑steroidal anti‑inflammatory drug (NSAID) with antiplatelet properties.

Investigated diseases

Myocardial infarction - It is a condition where part of the heart muscle is damaged because blood flow to that area is suddenly blocked. The blockage usually results from a clot forming in a coronary artery. When the heart muscle does not receive enough oxygen, the tissue can begin to die. The damage can spread outward from the center of the blocked area, leading to larger areas of impaired heart function. Over time, the affected region may become scar tissue, which can affect the heart’s ability to pump efficiently.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525159-20-00Protocol codeMHICC-2025-001Estimated enrolment2 570 patientsSponsorMontreal Heart Institute

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