AuthorisedTherapeutic use (Phase IV)Interventional

REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial

Many people with long-term heart disease take a daily low-dose aspirin to help prevent blood clots. While aspirin helps protect against heart attacks and strokes, it can also cause serious bleeding, especially in older adults. As people get older, the risk of bleeding in the stomach or brain can become higher than the heart benefits of the drug. This study, called the RELEASE trial, investigates whether older adults with stable heart conditions should continue taking daily 75 mg aspirin or safely stop it. Participants are split into two groups: one continues taking their regular daily aspirin, and the other stops. Researchers will follow participants over time using health records to see which choice offers the best balance between preventing clots and avoiding serious bleeds. The results will help doctors provide safer care for older heart patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Vestre Viken HF

Enrolment target

7,000

Start

15 Sep 2026

Chronic coronary syndrome

What is this study about?

Daily low-dose aspirin has long been a standard treatment for people with heart disease. Aspirin works by thinning the blood, which stops dangerous blood clots from forming inside the arteries. However, as people grow older, the risk of serious internal bleeding—especially in the stomach, gut, or brain—increases significantly. Doctors now want to know whether older patients who have been stable for a long time still need to take aspirin every day.

The RELEASE study aims to answer this question. It focuses on older adults living with chronic coronary syndrome, which is a stable, long-term heart condition. The trial compares what happens when patients stay on a daily 75 mg aspirin tablet against what happens when they stop taking it altogether. Researchers want to learn if stopping aspirin reduces major bleeding without increasing the chance of heart attacks or strokes.

Because this is a registry-based trial, researchers track participants' health through standard medical records. This means you do not have to travel for extra hospital visits just for the study. The findings will help doctors give clearer, safer advice to older people about whether aspirin is still helpful or if it is time to stop.

Key takeaways

The trial tests whether older adults with long-term heart disease should continue or safely stop daily aspirin.
Aspirin helps prevent heart attacks, but it also raises the risk of serious bleeding as you get older.
Participants either keep taking daily 75 mg aspirin or stop taking it.
Researchers follow your health through routine medical records, meaning fewer extra hospital trips.
Taking part is voluntary, and you can withdraw at any time without affecting your standard care.

Who may be eligible?

This trial is designed for older adults who have chronic coronary syndrome. This usually means you have had heart disease for some time, such as a previous heart attack, a stent placed in an artery, or stable angina, and you have been taking low-dose aspirin regularly to protect your heart.

Both men and women can take part. Because the trial is looking specifically at the balance of benefits and bleeding risks as people age, it focuses on older individuals.

You might not be able to join if you have a medical condition that requires you to stay on aspirin or other strong blood thinners. For instance, if you have recently had a new stent put in, or if you take other medicines to prevent blood clots, this trial may not be right for you. Your healthcare team will check your full medical history to see if it is safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an older adult with stable, long-term heart disease?
Have you been taking a daily low-dose aspirin (such as 75 mg)?
Has it been a long time since you had a heart attack, bypass surgery, or stent placed?
Are you free from other strong blood-thinning medicines that you cannot safely stop?

Answer every question to see your result.

What does participation involve?

If you take part, a computer will randomly place you into one of two groups. One group will continue taking their regular 75 mg low-dose aspirin tablet once a day. The other group will stop taking aspirin.

Because this study uses official health registries to follow your progress, taking part does not usually require extra clinic appointments, blood tests, or hospital visits. Researchers will simply keep track of your health records over several years to watch for any heart problems, strokes, or bleeding issues. You will carry on seeing your regular doctor and receiving your usual healthcare throughout the study.

Potential risks and benefits

The main benefit of taking part is helping doctors find out the safest way to treat older people with heart disease. If you stop taking aspirin, your risk of stomach ulcers and serious bleeding may go down, but there could be a slightly higher chance of a blood clot or heart event. If you keep taking aspirin, your heart protection continues, but your risk of bleeding stays the same. Joining is entirely your choice. You can leave the study at any time without giving a reason, and your normal medical care will not be affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

Why are doctors reconsidering daily aspirin?

Aspirin prevents blood clots, but it also increases the risk of bleeding. In older people, bleeding can be very dangerous, so doctors want to be sure the benefits still outweigh the risks.

What is Albyl-E?

Albyl-E is a brand of low-dose (75 mg) aspirin. It has a special coating that helps protect your stomach lining from irritation.

Will I need to visit the hospital more often?

No. The study tracks your health using existing medical registries, so you will not need extra hospital appointments purely for the trial.

What happens if I feel unwell during the trial?

You should contact your doctor or seek emergency medical help as normal. Your safety always comes first, and your doctor can restart your medicines if needed.

Can I choose whether I stop or keep taking aspirin?

No. A computer randomly decides which group you join so that the results are fair and reliable. However, you can leave the study at any point if you change your mind.