Discontinuing Acetylsalicylic Acid vs Continued Use in Patients ≥ 65 Years with Stable Chronic Coronary Syndrome

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What is this study about?

The trial focuses on people older than 65 who have stable chronic coronary syndrome, a condition that includes a history of ischemic heart disease such as previous myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting. The medication being studied is low‑dose aspirin, which is commonly used to help prevent new heart problems.

The purpose of the study is to determine whether stopping long‑term aspirin in this population is not worse than continuing it for overall health outcomes. Participants will be randomly assigned to either keep taking aspirin or to receive a harmless tablet that looks the same but contains no active drug (placebo). The study will follow participants for several years, checking in at regular intervals.

During the follow‑up, researchers will record events such as cardiovascular death, fatal bleeding, intracranial bleeding, ischemic stroke, MI and other serious bleeding problems, as well as less severe issues like peptic ulcer, angina, and overall quality of life. The information collected will help decide if stopping aspirin is a safe option for older adults with stable heart disease.

1 baseline assessment

after joining, you attend an initial visit where health information is recorded, including heart condition history and current medicines.

a physical exam, blood tests, and an electrocardiogram may be performed to document the current status.

2 randomization

based on the information collected, you are assigned to one of two groups: continue taking aspirin or stop taking aspirin.

the assignment is done by a computer system to ensure fairness.

3 medication instructions

if assigned to continue, you receive magnyl dak, enterotabletter or hjertemagnyl, filmovertrukne tabletter 75 mg, each containing 150 mg of acetylsalicylic acid.

the tablet is taken by mouth once each day.

if assigned to stop, you are asked not to take any aspirin tablets for the duration of the study.

4 daily medication intake

you take the tablet at the same time each day, preferably with food to reduce stomach discomfort.

the treatment continues for the whole study period, which may last up to three years.

5 regular follow‑up visits

you attend scheduled visits every three to six months to check health status, report any bleeding, chest pain, or other symptoms, and to collect new study medication if needed.

during each visit, brief questionnaires about quality of life and any side effects are completed.

6 reporting adverse events

if you notice unusual bleeding, severe stomach pain, or any new health problem, you are instructed to inform the study team immediately, usually by phone or electronic message.

7 study completion

at the end of the study period, a final assessment is performed, including the same tests as at baseline.

information collected throughout the trial is used to compare outcomes between the two groups.

Who Can Join the Study?

Be at least 65 years old when you join the study.
Have a history of ischemic heart disease that caused a major heart event such as a heart attack (myocardial infarction, MI), a procedure to open a blocked artery called percutaneous coronary intervention (PCI), or heart‑bypass surgery known as coronary artery bypass grafting (CABG) that happened more than two years ago.
Since that heart event, you must not have had any new heart‑related problems like another heart attack, an ischemic stroke (a stroke caused by a blocked blood vessel), a transient ischemic attack (TIA) (a brief, temporary stroke‑like episode), or any repeat procedures to open or bypass heart arteries (additional PCI or CABG).
Currently be taking a low‑dose aspirin (150 mg or less each day), as shown by your prescription records or what you report yourself.

Who Cannot Join the Study?

You have ever had an ischemic stroke, which is a type of brain attack caused by a blocked blood vessel.
You are currently taking, or need, medicines that thin the blood such as anti‑coagulants or drugs called P2Y12‑inhibitors.

peripheral artery disease

You have had a procedure to improve blood flow in the arms or legs, known as a revascularization procedure for peripheral artery disease.
You have a history of a clot forming in a heart stent (called stent thrombosis) or you have had a stent placed in the main artery of the heart (left main coronary artery).

contraindications

You are unable to understand Danish, the language used for the study information.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Roskilde University	Roskilde	Denmark
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.09.2026

Trial locations

Investigated Drugs:

Acetylsalicylic Acid

Aspirin (Magnyl DAK, enteric‑coated tablet) is a low‑dose aspirin taken by mouth in a tablet that is designed to dissolve later in the intestine. It works by making the blood less likely to form clots, which helps protect people with heart disease from heart attacks and strokes. In this study the drug is given to participants who continue taking aspirin, so researchers can see how well staying on aspirin works over time.

Aspirin (Hjertemagnyl, film‑coated tablet) is another low‑dose aspirin taken by mouth, but it comes as a tablet with a thin coating that helps it swallow easily. Like other aspirin, it reduces the chance of blood clots forming, which can lower the risk of heart attacks and strokes. This formulation is also used in the trial for participants who keep taking aspirin, allowing comparison with the group that stops the drug.

Aspirin discontinuation (no aspirin) is the strategy of stopping long‑term aspirin use in people over 65 with stable heart disease. Participants assigned to this group stop taking any aspirin tablets, and the study looks at whether their overall health outcomes are similar to those who keep taking aspirin. This approach helps determine if it is safe to stop aspirin in older patients.

Investigated Diseases:

Chronic coronary syndrome – It is a long‑term condition in which the coronary arteries become narrowed, limiting blood flow to the heart muscle. Over time, the reduced blood supply can cause chest discomfort, especially during physical activity. The narrowing may slowly worsen, leading to more frequent symptoms or episodes of heart muscle injury. Some people experience sudden blockages that cause a heart attack, while others have a gradual decline in heart function. The disease often progresses silently, with symptoms becoming noticeable only when the heart’s oxygen needs increase.

Trial ID:

2026-525442-30-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Discontinuing Acetylsalicylic Acid vs Continued Use in Patients ≥ 65 Years with Stable Chronic Coronary Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?