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

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What is this study about?

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.

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.

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).

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Haukeland Universitetssjukehus	Bergen	Norway
Sorlandet Sykehus HF	Arendal	Norway
Syaptpvne Uwqlczglyt Hogmuivw Ho	Stavanger	Norway
Vqqzhb Vyspe Hx	Drammen	Norway
Agmyjvmm Usarrpusna Htpodhmk	Lorenskog	Norway
Ujjuqdeynheykiscucelw Nvbtjjgjbz Ha	Tromsø	Norway
Sad Ohsne Hwgdyqxt Hi	Trondheim	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	04.01.2027

Trial locations

Investigated Drugs:

Acetylsalicylic Acid

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.

Investigated Diseases:

Coronary artery disease

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.

Trial ID:

2026-526941-91-00

Protocol code:

RELASE

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?