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Study on Reducing Bleeding by Omitting Aspirin in Patients with Non-ST Elevation Acute Coronary Syndrome

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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 Non-ST-segment elevation acute coronary syndrome (NSTE-ACS). This condition is a type of heart problem that can lead to chest pain or heart attacks. The study is exploring the effects of not using a common medication called aspirin in patients with this condition. Aspirin is often used to prevent blood clots, but it can also cause bleeding. The medication being studied is called Acetylsalicylzuur Cardio Aurobindo 80 mg, which is a form of aspirin in a dispersible tablet.

The purpose of the study is to find out if stopping aspirin can reduce the risk of bleeding without increasing the risk of heart-related problems like heart attacks or strokes. Participants in the study will be monitored over a period of time to see if they experience any major or minor bleeding or other heart-related events. The study aims to compare the outcomes of patients who continue taking aspirin with those who do not, to see if the latter group experiences less bleeding while still being protected from heart issues.

Throughout the study, participants will be given either the aspirin medication or a placebo, and their health will be closely observed. The study will last for up to 12 months, during which time the researchers will collect data on any bleeding incidents and heart-related events. The goal is to determine if omitting aspirin is a safe and effective option for patients with Non-ST-segment elevation acute coronary syndrome.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, the patient will be enrolled based on specific criteria. The patient must have a clinical diagnosis of non-ST-segment elevation acute coronary syndrome (NSTE-ACS), which includes conditions like non-ST elevation myocardial infarction (NSTEMI) or unstable angina. Additionally, the patient must have undergone a successful percutaneous coronary intervention (PCI), as determined by the treating physician.
Step 2
Medication administration
The patient will be administered a medication called acetylsalicylic acid, commonly known as aspirin, in the form of a dispersible tablet. The dosage is 80 mg, and it is taken orally. The frequency and duration of administration will be determined by the study protocol, which aims to assess the effects of omitting aspirin on bleeding and ischemic events.
Step 3
Monitoring and follow-up
Throughout the trial, the patient will be monitored for any signs of bleeding or ischemic events such as heart attacks or strokes. The primary focus is to evaluate major or minor bleeding incidents, as defined by the Bleeding Academic Research Consortium (BARC) criteria, and a composite of all-cause mortality, myocardial infarction, and stroke over a period of 12 months.
Step 4
Completion
The trial is expected to conclude by August 1, 2027. At the end of the study, the collected data will be analyzed to determine the effectiveness and safety of the treatment approach.

Who can join the trial?

4 criteria

Must have a clinical diagnosis of Non-ST-segment elevation acute coronary syndrome (NSTE-ACS), which includes conditions like NSTEMI (a type of heart attack) or unstable angina (a condition where the heart doesn't get enough blood flow and oxygen).
Must have had a successful PCI (Percutaneous Coronary Intervention), which is a procedure to open up blood vessels in the heart, as determined by the treating doctor.
Open to both male and female participants.
Participants should not be part of a vulnerable population, meaning they should be able to give informed consent and not be in a situation where they are at risk of being coerced or unduly influenced.

Who cannot join the trial?

8 criteria

Patients with a history of **severe bleeding** or conditions that increase the risk of bleeding cannot participate. **Severe bleeding** refers to any significant loss of blood that could be life-threatening or require medical intervention.
Patients who have had a **stroke** in the past six months are excluded. A **stroke** is a medical condition where poor blood flow to the brain results in cell death.
Patients with **severe liver disease** are not eligible. **Severe liver disease** refers to serious conditions affecting the liver, which can impair its function.
Patients with **kidney failure** requiring dialysis cannot take part. **Kidney failure** is when the kidneys are no longer able to work as they should to filter waste from the blood.
Patients who are currently participating in another clinical trial are excluded.
Pregnant or breastfeeding women cannot participate in the study.
Patients with known allergies to the study medication or similar drugs are not eligible.
Patients with any other medical condition that the study doctors believe would make participation unsafe are excluded.

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Verified sites

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Academisch Ziekenhuis Leiden
Responsive
Leiden, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

Aspirin is a medication commonly used to reduce pain, fever, or inflammation. In the context of this clinical trial, aspirin is typically used to prevent blood clots in patients with heart conditions. The study is exploring whether not using aspirin can reduce bleeding risks while still effectively preventing heart-related issues.

Acetylsalicylic Acid

What is already known about the treatment

Aspirin – Aspirin is typically taken orally in the form of a tablet. It is a well-known medication used to reduce pain, fever, and inflammation, and it is also used to prevent blood clots. In the context of non-ST-segment elevation acute coronary syndrome, aspirin is commonly used to prevent further heart-related complications. It works by inhibiting an enzyme called cyclooxygenase, which in turn reduces the production of substances that promote inflammation and blood clotting. Aspirin is classified as a nonsteroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.

Investigated diseases

Non-ST-segment elevation acute coronary syndrome – This condition is a type of acute coronary syndrome that occurs when there is a significant reduction in blood flow to the heart, but not a complete blockage. It is characterized by chest pain or discomfort that may spread to the arms, neck, jaw, or back. Unlike ST-segment elevation myocardial infarction, it does not show the specific changes in the ST segment on an electrocardiogram. The progression involves the potential for worsening chest pain and the risk of heart muscle damage if blood flow is not restored. Over time, it can lead to complications such as heart failure or arrhythmias. The condition requires careful monitoring to prevent further cardiac events.