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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium
Stichting OLVG	Amsterdam	The Netherlands

Other Sites

Site Name	City	Country
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Medisch Centrum Leeuwarden B.V.	Leeuwarden	The Netherlands
CHC MontLegia	Liege	Belgium
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Isala Klinieken Stichting	Zwolle	The Netherlands
Amsterdam UMC	Amsterdam	The Netherlands
Stichting Treant Ziekenhuiszorg	Emmen	The Netherlands
Haga Hospital	Hague	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
CHU Helora	La Louviere	Belgium
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Vrije Universiteit Brussel	Jette	Belgium
Tergooiziekenhuizen	Hilversum	The Netherlands
Suurgalew Ritjmeh Utaekagbnu Mfmntew Cbvbvo	Nijmegen	The Netherlands
Arsduehnj Uqt	Amsterdam	The Netherlands
Hrb Zysipsjpsarvwgzlo Ayaykssbt	Antwerp	Belgium
Edaaznw Uxkofawxmgpb Mfykpru Czslbvz Rjeqrpiri (zbnfuzv Mso	Rotterdam	The Netherlands
Rjrphqdts Zpocpawmja Sxxtqgwyx	Arnhem	The Netherlands
Ovplstiowyimaqmeptfitadlnd	Aalst	Belgium
Iwuqrs	Bonheiden	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	13.05.2022
The Netherlands	Not recruiting	13.05.2022

Trial locations

Investigated drugs:

Acetylsalicylic Acid

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.

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.

Trial ID:

2023-504360-42-00

NCT ID:

NCT05125276

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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