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Study Comparing Aspirin Alone to Aspirin and Fondaparinux in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI)

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 a heart condition known as Non-ST-Elevation Myocardial Infarction (NSTEMI). This condition is a type of heart attack that does not show the typical changes on an electrocardiogram (ECG) that are seen with other heart attacks. The study will compare two treatment approaches for patients with NSTEMI. One group will receive aspirin alone, while the other group will receive a combination of aspirin and fondaparinux sodium. Aspirin is a common medication used to reduce pain, fever, and inflammation, and it also helps prevent blood clots. Fondaparinux sodium is a medication that helps prevent blood clots by inhibiting a specific factor in the blood clotting process.

The purpose of this study is to compare the effectiveness of aspirin alone versus the combination of aspirin and fondaparinux sodium in patients with NSTEMI. Participants in the study will be randomly assigned to one of the two treatment groups. The study will monitor the participants over a period of time to observe outcomes such as survival rates, the occurrence of new heart attacks, and other related health events. The study aims to provide insights into which treatment approach may offer better outcomes for patients with NSTEMI.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to gather data on the effectiveness of the treatments. The study will also track other health indicators, such as the length of hospital stay and heart function at the time of discharge. This research is expected to contribute valuable information to the medical community about the best treatment strategies for managing NSTEMI.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm the diagnosis of non-ST-elevation myocardial infarction (NSTEMI). This involves checking for a rise or fall in cardiac troponin levels and symptoms of acute heart issues, or changes in the electrocardiogram (ECG) that are compatible with acute heart issues.
Eligibility criteria include being over 18 years of age, having an expected remaining lifespan of more than one year, and the ability to provide informed written and oral consent.
Step 2
Medication administration
Participants are divided into two groups. One group receives acetylsalicylic acid (commonly known as aspirin) orally. The other group receives a combination of acetylsalicylic acid orally and fondaparinux sodium via subcutaneous injection.
The dosage, frequency, and duration of administration are determined by the study protocol and are explained to participants during this phase.
Step 3
Monitoring and follow-up
Participants are monitored for a composite endpoint, which includes 30-day mortality, new myocardial infarction (MI) within 30 days, and refractory ischemia that results in acute coronary angiography (CAG) before it is scheduled.
Secondary endpoints include the occurrence of death or new MI within 180 days, 1 year, 3 years, 5 years, and 10 years, incidence of cerebrovascular accidents (CVA) within 30 days, length of hospital stay, and left ventricular ejection fraction (LVEF) at discharge.
Step 4
Study duration
The study is expected to end by July 1, 2027. Participants are followed up according to the study schedule to assess the long-term outcomes and safety of the treatments.

Who can join the trial?

4 criteria

Must have a diagnosis of Non-ST-Elevation Myocardial Infarction (NSTEMI). This is a type of heart attack that is confirmed by a rise or fall in a protein called cardiac troponin, along with symptoms of heart problems or changes in an ECG (a test that checks the heart's electrical activity).
Must be older than 18 years.
Must have an expected remaining lifespan of more than 1 year.
Must be able to make decisions independently and provide written and spoken consent to participate in the study.

Who cannot join the trial?

3 criteria

Patients who have a different type of heart attack than the one being studied, called Non-ST-Elevation Myocardial Infarction (NSTEMI), cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Gentofte Hospital
Hellerup, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Aspirin
is a medication commonly used to reduce pain, fever, or inflammation. In this trial, it is being used to help prevent blood clots in patients with a type of heart attack known as NSTEMI (Non-ST-Elevation Myocardial Infarction). Aspirin works by making the blood less sticky, which helps to prevent clots from forming in the blood vessels.
Fondaparinux
is a medication that helps prevent blood clots. It is often used in patients with certain types of heart conditions, like NSTEMI, to reduce the risk of complications. Fondaparinux works by blocking a specific factor in the blood clotting process, which helps to keep the blood flowing smoothly. In this trial, it is being used in combination with aspirin to see if it provides better protection against heart-related issues compared to using aspirin alone.

What is already known about the treatment

Aspirin
Aspirin is typically administered orally in tablet form. It is a well-established medication in medical literature, widely used for its anti-inflammatory and blood-thinning properties. The main therapeutic indication for aspirin in this context is to manage Non-ST-Elevation Myocardial Infarction (NSTEMI). At the molecular level, aspirin works by inhibiting an enzyme called cyclooxygenase, which reduces the production of substances that promote inflammation and blood clotting. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.
Fondaparinux
Fondaparinux is administered via subcutaneous injection. It is recognized in medical literature as an anticoagulant used to prevent and treat blood clots. In the context of NSTEMI, fondaparinux is used to prevent clot formation in the arteries of the heart. Its mechanism of action involves selectively inhibiting factor Xa, an essential component in the blood coagulation process. Fondaparinux is classified as a synthetic pentasaccharide anticoagulant.

Investigated diseases

Non-ST-Elevation Myocardial Infarction (NSTEMI) – This is a type of heart attack that occurs when blood flow to the heart muscle is partially blocked, leading to damage. Unlike other heart attacks, NSTEMI does not show the classic elevation in the ST segment on an electrocardiogram. Symptoms may include chest pain, shortness of breath, and fatigue. The condition progresses as the heart muscle becomes more damaged due to reduced blood supply. Over time, this can lead to complications such as heart failure or arrhythmias. It is important to manage risk factors to prevent further heart issues.