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Continuing vs Stopping Acetylsalicylic Acid in Elderly Patients with Chronic Coronary Syndrome (Secondary Prevention): A Randomized Trial

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

The study focuses on people with Chronic coronary syndrome, a condition where the arteries that supply the heart become narrowed, which can cause chest pain or increase the risk of a heart attack. The medication being examined is a low‑dose form of aspirin, a drug that helps prevent blood clots from forming inside the arteries. Participants are older adults who have already had a heart event such as a heart attack or unstable angina two to eight years ago.

The purpose of the trial is to find out whether stopping aspirin is safer or more harmful than continuing it, by looking at serious outcomes such as death from heart problems, heart attacks, strokes, and major bleeding that requires a hospital stay. Participants will be randomly placed into one of two groups: one will keep taking the aspirin tablets, and the other will stop taking them, and they will be followed for several years to see what health events occur.

After the random assignment, participants will either continue with the aspirin tablets or take no study medication, following the instructions given by the study team. Throughout the study, they will have regular check‑ins where they report any new health issues, hospital admissions, or changes in other medicines. This information will be used to compare overall health outcomes between the two groups.

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
Randomization
After joining the study, you will be randomly placed into one of two groups. the random assignment occurs 2 to 8 years after your previous heart event and determines whether you will keep taking aspirin or stop it.
Step 2
Receive medication instructions
The study team will give you written and verbal instructions about the medication called albyl-e. the tablet is taken by mouth, is gastro‑resistant, and contains 150 mg of acetylsalicylic acid (aspirin).
Step 3
Obtain prescription and start aspirin (continuation group)
If you are assigned to continue aspirin, you must fill a prescription for albyl-e. the study protocol counts the medication as taken when at least two prescriptions are filled between one month before and six months after randomization.
Take one tablet each day, at the same time each day, for the whole study period unless you experience a serious side effect or are told otherwise by your doctor.
Step 4
Discontinue aspirin (withdrawal group)
If you are assigned to stop aspirin, you should not take any aspirin tablets after the randomization date.
You do not need to obtain a new prescription, but you should keep the study staff informed if you accidentally take aspirin.
Step 5
Ongoing daily routine
Continue the daily routine that matches your assignment: take the tablet each day if you are in the continuation group, or avoid aspirin if you are in the withdrawal group.
The study will continue until the planned end date in december 2030 or until you experience a defined clinical event.
Step 6
Follow‑up monitoring
The study will track hospital visits for heart attack, stroke, bleeding, or death. if you are hospitalized for any of these reasons, the study team will record the event.
You may be asked to provide information about these events during routine follow‑up contacts.

Who can join the trial?

3 criteria

Be at least 65 years old when you join the study and be taking a low‑dose aspirin (a small amount of a common blood‑thinner, 150 mg or less each day).
Have had an acute coronary syndrome (ACS) event – a serious heart problem such as a heart attack – that was treated with a procedure called percutaneous coronary intervention (PCI, a tiny tube used to open a blocked artery) between 2 and 8 years before joining the study, and have not had any new heart attacks, strokes, or additional heart‑opening procedures (like another PCI or coronary artery bypass grafting, which is surgery to reroute blood around blocked arteries) since that original event.
Sign a consent form showing you understand the study and agree to follow the study rules, and be willing to cooperate as required by international and local research guidelines (known as ICH/GCP).

Who cannot join the trial?

5 criteria

If you need a blood‑thinning medicine called an antiplatelet drug for a reason other than preventing another heart problem (secondary prevention of coronary artery disease (CAD)), such as a blood disorder, a previous stroke, or peripheral artery disease (PAD), you cannot join the study.
If you are currently taking or need to take an anti‑coagulant (a medication that prevents clotting) or a P2Y12‑inhibitor (a specific type of antiplatelet drug), you are excluded.
If you have a blockage in the main artery of the heart (left main stenosis), have ever had a clot form in a stent (stent thrombosis), or your doctor believes stopping aspirin would be unsafe (contraindications), you cannot participate.
If you have a condition or situation that the doctor thinks could put you at high risk, confuse the study results, make it hard for you to take part, or prevent you from giving proper informed consent—for example, drug or alcohol abuse or dementia—you will be excluded. (Patients are not excluded only because of older age, frailty, or taking many medicines (polypharmacy) if consent is possible.)
If you are expected to live less than 12 months for reasons unrelated to heart disease (life expectancy < 12 months) or cannot understand Norwegian or English, you cannot be enrolled.

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Verified sites

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

Akershus University Hospital
Verified
Lorenskog, Norway
Oslo Universitetssykehus HF
Verified
Oslo, Norway
St. Olavs Hospital HF
Verified
Trondheim, Norway

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Investigated drugs

Aspirin (Albyl‑E) is a medication that helps prevent blood clots by making platelets less likely to stick together. In this study, participants who had previously suffered a heart attack or similar event were asked to either keep taking aspirin or stop taking it. The purpose was to see whether continuing aspirin would lower the risk of future heart problems, strokes, or serious bleeding compared with stopping the drug.

Acetylsalicylic Acid

What is already known about the treatment

Albyl‑E 75 mg enterotabletter - This medication is taken by mouth as a gastro‑resistant tablet that releases the drug in the intestine. It contains acetylsalicylic acid, a well‑known and widely used drug that is approved for many years to help prevent heart problems. The main use is to lower the risk of heart attacks and strokes in people who have already had coronary artery disease. It works by blocking an enzyme called COX‑1 in platelets, which reduces the platelets’ ability to form clots, and it belongs to the antiplatelet (non‑steroidal anti‑inflammatory) class of medicines.

Investigated diseases

Chronic coronary syndrome - It is a condition in which the arteries that supply the heart become gradually narrowed, reducing blood flow. The narrowing usually develops slowly as plaque builds up inside the vessel walls. People often feel chest discomfort or pressure during physical activity, and this can become more common as the disease advances. The reduced blood flow may cause the heart muscle to receive less oxygen, leading to episodes of damage if the blockage worsens. Over time the narrowing can progress, increasing the frequency of symptoms and the risk of heart-related events.