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Study on Ticagrelor for Patients with Heart Attack After Coronary Stenting

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 a medication called ticagrelor, which is used in patients who have experienced a myocardial infarction, commonly known as a heart attack. The study is specifically looking at patients who have undergone a procedure called coronary stenting, where a small tube is placed in the heart's blood vessels to keep them open. The purpose of the study is to evaluate the initial safety of using ticagrelor alone, without other medications, after this procedure.

Participants in the study will take Brilique 90 mg film-coated tablets, which contain ticagrelor, for a period of time. The study will monitor the participants for any serious heart-related events, such as cardiac death, another heart attack, or issues with the stent, within the first three months. Additionally, the study will observe the occurrence of bleeding events and other health outcomes over a period of up to 12 months.

The study aims to gather information on how safe it is to use ticagrelor as a single treatment after a heart attack and stenting. This will help doctors understand if this approach can be a reliable option for patients in the future. Participants will be closely monitored throughout the study to ensure their safety and to collect valuable data on the effects of the medication.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after signing and dating the informed consent form.
Eligibility includes being at least 18 years old and having undergone coronary stenting with an everolimus-eluting stent due to a heart attack.
Step 2
Medication administration
The medication used is Brilique 90 mg film-coated tablets, containing the active substance ticagrelor.
The tablets are taken orally as a monotherapy, meaning no other similar medications are used alongside.
Step 3
Initial treatment phase
The study evaluates the safety of using ticagrelor alone after coronary stenting.
No post-procedure dose of aspirin or other P2Y12 inhibitors is administered.
Step 4
Monitoring and follow-up
Primary outcomes are monitored for 3 months, focusing on cardiac death, heart attacks, or stent thrombosis.
Secondary outcomes are assessed at 3 and 12 months, including bleeding events, stent thrombosis, heart attacks, and overall mortality.
Step 5
Platelet reactivity assessment
Platelet reactivity is measured using the ADP-test at 24 hours and 3 months to evaluate the effectiveness of ticagrelor.
Step 6
Study completion
The study is estimated to conclude by December 31, 2025.

Who can join the trial?

6 criteria

Men or women who are at least 18 years old can participate.
Participants must have been treated with **ticagrelor** before or during the procedure. **Ticagrelor** is a medication that helps prevent blood clots.
Participants must have had a **coronary stenting** procedure using an **everolimus-eluting stent (EES)** due to a heart attack. **Coronary stenting** is a procedure to open up blood vessels in the heart. An **everolimus-eluting stent** is a small tube placed in the artery that releases medication to prevent blockage.
After the procedure, the artery should have less than 50% blockage, and blood flow should be normal, known as **Thrombolysis In Myocardial Infarction (TIMI) flow grade 3**.
Participants should not have received any dose of **aspirin** or any other medication similar to **ticagrelor** after the procedure. However, taking these medications before the procedure is allowed.
Participants must have signed and dated the informed consent form, which means they agree to take part in the study after understanding what it involves.

Who cannot join the trial?

4 criteria

Patients who have had a myocardial infarction, which is commonly known as a heart attack.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specified clinical trial group.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden

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Investigated drugs

Ticagrelor is a medication used to prevent blood clots in patients who have had a heart attack. In this clinical trial, it is being tested as a single therapy after patients have undergone a procedure called coronary stenting, which is used to open up blocked arteries in the heart. The goal of the trial is to evaluate the safety of using ticagrelor alone in these patients.

Ticagrelor

What is already known about the treatment

Ticagrelor – Ticagrelor is administered orally in tablet form and is currently being studied in clinical trials for its use after coronary stenting in patients who have experienced an acute myocardial infarction. It is an antiplatelet medication, which means it helps prevent blood clots by inhibiting platelet aggregation. At the molecular level, ticagrelor works by reversibly binding to the P2Y12 receptor on platelets, blocking the action of adenosine diphosphate (ADP), which is a substance that promotes platelet activation and aggregation. This medication is primarily used to reduce the risk of heart attack or stroke in individuals with certain heart conditions.

Investigated diseases

Myocardial infarction – This condition, 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. The blockage is often caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. When a plaque ruptures, it can form a clot that blocks blood flow. Symptoms may include chest pain, shortness of breath, and discomfort in the upper body. The progression of the disease can lead to complications such as heart failure or arrhythmias if not managed properly. It is a critical condition that requires immediate medical attention to restore blood flow and minimize heart damage.