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Study on the Safety of Ticagrelor and Aspirin in Patients with ST-Elevation Myocardial Infarction After Heart Procedure

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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 a heart condition known as ST-elevation myocardial infarction (STEMI), which is a severe type of heart attack. The study is investigating the safety of using a medication called ticagrelor on its own after a procedure known as primary percutaneous coronary intervention (PCI), which is used to treat STEMI. The trial will compare two treatment strategies: one where patients take only ticagrelor for 12 months, and another where patients take both ticagrelor and aspirin for the same period. The aim is to see if using ticagrelor alone is just as safe as using both medications together in terms of preventing further heart-related issues.

Participants in the study will undergo the PCI procedure, which helps open blocked blood vessels in the heart. After the procedure, they will be assigned to one of the two treatment groups. The study will monitor the occurrence of any heart-related events and the extent of bleeding within the heart muscle, known as intramyocardial hemorrhage (IMH), during the first week after the procedure. The trial will last for 12 months, during which the safety and effectiveness of the treatments will be assessed.

The study will also look at other factors, such as the risk of bleeding, overall survival, and how the medications affect blood clotting and inflammation in the body. By comparing these two treatment approaches, the trial aims to provide valuable information on the best way to manage patients who have experienced a STEMI. The findings could help improve treatment strategies and outcomes for individuals with this serious heart condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after a diagnosis of ST elevation myocardial infarction (STEMI) and a successful procedure called percutaneous coronary intervention (PCI).
Eligibility is confirmed by the treating physician based on clinical and electrocardiographic criteria.
Step 2
Initial treatment phase
Following the PCI, the treatment involves the use of ticagrelor, a medication that helps prevent blood clots.
The study aims to compare two treatment strategies: one with ticagrelor alone and another with ticagrelor plus acetylsalicylic acid (aspirin).
Step 3
Medication administration
If assigned to the ticagrelor plus aspirin group, take acetylsalicylic acid orally in the form of an 80 mg tablet.
The duration of this treatment is 12 months.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the safety and effectiveness of the treatment.
The primary focus is on the occurrence of major adverse cardiac and cerebral events, such as heart attacks, stent thrombosis, ischemic strokes, and cardiovascular mortality.
Step 5
Imaging and evaluation
Between days 5 and 8 after the PCI, a cardiac magnetic resonance (CMR) scan is performed to evaluate the size of the heart attack and any bleeding within the heart muscle.
This helps in understanding the impact of the treatment on heart health.
Step 6
Secondary assessments
Additional evaluations include checking for bleeding complications, overall mortality, and the body's response to inflammation and blood clotting.
These assessments help in comparing the effects of ticagrelor alone versus ticagrelor with aspirin.
Step 7
Completion of the study
The study is expected to conclude by December 1, 2025.
Final results will contribute to understanding the best treatment approach for patients with STEMI.

Who can join the trial?

6 criteria

The patient must have a clinical and electrocardiographical diagnosis of STEMI. This means they have a specific type of heart attack that shows certain patterns on an ECG, a test that records the heart's electrical activity.
The patient must have had a successful PCI of the infarct-related vessel. PCI stands for percutaneous coronary intervention, a procedure to open up blood vessels in the heart that have been narrowed by plaque buildup. The treating doctor must consider the procedure successful.
The patient must have received a modern DES. DES stands for drug-eluting stent, which is a small tube placed in the artery to keep it open and release medication to prevent blockage.
The patient must be within the age range of 18 to 80 years old.
Both male and female patients are eligible to participate.
The patient should not belong to a vulnerable population, meaning they should not be in a group that might need special protection or care.

Who cannot join the trial?

4 criteria

Patients who have not experienced a ST elevation myocardial infarction (STEMI). This is a type of heart attack where there is a long interruption to the blood supply, causing a part of the heart muscle to be damaged.
Patients who are not within the specified age range for the study.
Patients who belong to a clinical trial group that is not included in this study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Amsterdam UMC
Amsterdam, The Netherlands
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Rijnstate Ziekenhuis Stichting
Arnhem, The Netherlands
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Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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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 to see if it is safe and effective when used alone for 12 months after a heart procedure called primary percutaneous coronary intervention (PCI) in patients with a type of heart attack known as ST-elevation myocardial infarction (STEMI). The trial aims to determine if using ticagrelor alone can prevent further heart-related issues without increasing the risk of bleeding inside the heart muscle.
Aspirin
is a common medication used to reduce pain, fever, and inflammation, and it also helps prevent blood clots. In this trial, aspirin is used in combination with ticagrelor for 12 months after the heart procedure to see if this combination is as safe as using ticagrelor alone. The study compares the two approaches to understand their effects on preventing heart problems and the risk of bleeding inside the heart muscle.

Acetylsalicylic Acid

What is already known about the treatment

Ticagrelor – Ticagrelor is administered orally in tablet form. It is currently well-established in medical practice and literature, particularly for its role in managing heart conditions. The main therapeutic indication for ticagrelor is to reduce the risk of heart attack or stroke in patients with acute coronary syndrome, such as ST-elevation myocardial infarction (STEMI). At the molecular level, ticagrelor works by inhibiting platelet aggregation, which prevents blood clots from forming. It belongs to the pharmacological class of antiplatelet agents.

Investigated diseases

ST Elevation Myocardial Infarction (STEMI) – This is a type of heart attack characterized by a significant elevation in the ST segment on an electrocardiogram, indicating a complete blockage of a coronary artery. It occurs when a blood clot forms on a ruptured plaque in a coronary artery, leading to a sudden reduction in blood flow to a part of the heart muscle. As a result, the affected heart muscle begins to die if the blockage is not quickly removed. Symptoms typically include chest pain, shortness of breath, and other signs of reduced blood flow. The progression of STEMI can lead to complications such as heart failure or arrhythmias if not promptly treated. Immediate medical intervention is crucial to restore blood flow and minimize heart damage.